Title: VALID Act of 2021
Policy area: Health

Summary:
Verifying Accurate Leading-edge IVCT Development Act of 2021 or the VALID Act of 2021
This bill requires the Food and Drug Administration (FDA) to regulate in vitro clinical tests (IVCTs).
Currently, the FDA and the Centers for Medicare & Medicaid Services have authority to regulate in vitro diagnostic devices. The bill defines IVCTs, which includes in vitro diagnostic devices, as tests intended for the collection, preparation, analysis, or in vitro clinical examination of specimens from the human body to provide information about a disease, condition, or treatment.
An IVCT may not be introduced into interstate commerce unless it has received FDA premarket approval or is covered by certain exemptions, such as an exemption for a test that (1) was developed and introduced before this bill's enactment and meets certain requirements, (2) is a low-risk test, (3) is solely for public health surveillance, (4) is covered by a technology certification issued under this bill, or (5) has received a humanitarian exemption or emergency use authorization.
The FDA may grant upon application a technology certification. Generally, such a certification covers a group of tests that use a single technology and may be evaluated using a representative test. While such a certification is valid, a qualifying IVCT that falls within the scope of the certification shall be cleared for interstate commerce.
The bill also imposes various requirements related to IVCTs, including those related to quality control, labeling, and reporting adverse events.
The FDA shall have various enforcement authority, including authority to order the recall of an IVCT with a reasonable probability of causing serious adverse health consequences.

[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4128 Introduced in House (IH)]

<DOC>






117th CONGRESS
  1st Session
                                H. R. 4128

 To amend the Federal Food, Drug, and Cosmetic Act to provide for the 
     regulation of in vitro clinical tests, and for other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             June 24, 2021

  Ms. DeGette (for herself and Mr. Bucshon) introduced the following 
    bill; which was referred to the Committee on Energy and Commerce

_______________________________________________________________________

                                 A BILL


 
 To amend the Federal Food, Drug, and Cosmetic Act to provide for the 
     regulation of in vitro clinical tests, and for other purposes.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

    (a) Short Title.--This Act may be cited as the ``Verifying Accurate 
Leading-edge IVCT Development Act of 2021'' or the ``VALID Act of 
2021''.
    (b) Table of Contents.--The table of contents of this Act is as 
follows:

Sec. 1. Short title; table of contents.
Sec. 2. Definitions.
Sec. 3. Regulation of in vitro clinical tests.
                ``subchapter j--in vitro clinical tests

        ``Sec. 587. Definitions.
        ``Sec. 587A. Applicability.
        ``Sec. 587B. Premarket review.
        ``Sec. 587C. Breakthrough in vitro clinical tests.
        ``Sec. 587D. Technology certification.
        ``Sec. 587E. Mitigating measures.
        ``Sec. 587F. Regulatory pathway redesignation.
        ``Sec. 587G. Advisory committees.
        ``Sec. 587H. Request for informal feedback.
        ``Sec. 587I. Registration and listing.
        ``Sec. 587J. Test design and quality requirements.
        ``Sec. 587K. Labeling requirements.
        ``Sec. 587L. Adverse event reporting.
        ``Sec. 587M. Corrections and removals.
        ``Sec. 587N. Restricted in vitro clinical tests.
        ``Sec. 587O. Appeals.
        ``Sec. 587P. Accredited persons.
        ``Sec. 587Q. Recognized standards.
        ``Sec. 587R. Investigational use.
        ``Sec. 587S. Collaborative communities for in vitro clinical 
                            tests.
        ``Sec. 587T. Comprehensive test information system.
        ``Sec. 587U. Preemption.
        ``Sec. 587V. Adulteration.
        ``Sec. 587W. Misbranding.
        ``Sec. 587X. Postmarket surveillance.
        ``Sec. 587Y. Electronic format for submissions.
        ``Sec. 587Z. Postmarket remedies.
Sec. 4. Enforcement and other provisions.
Sec. 5. Transition.
Sec. 6. Emergency use authorization.
Sec. 7. Antimicrobial susceptibility tests.
Sec. 8. Combination products.
Sec. 9. Resources.

SEC. 2. DEFINITIONS.

    (a) In General.--Section 201 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 321) is amended--
            (1) by adding at the end the following:
    ``(ss)(1) The term `in vitro clinical test'--
            ``(A) means a test intended by its developer (as defined in 
        section 587) to be used in the collection, preparation, 
        analysis, or in vitro clinical examination of specimens taken 
        or derived from the human body for the purpose of--
                    ``(i) identifying or diagnosing a disease or 
                condition;
                    ``(ii) providing information for diagnosing, 
                screening, measuring, detecting, predicting, 
                prognosing, analyzing, or monitoring a disease or 
                condition, including by making a determination of an 
                individual's state of health; or
                    ``(iii) selecting, monitoring, or informing therapy 
                or treatment for a disease or condition; and
            ``(B) may include--
                    ``(i) a test protocol or laboratory test protocol;
                    ``(ii) an instrument (as defined in section 
                587(11));
                    ``(iii) a specimen receptacle;
                    ``(iv) software, excluding software that is 
                excluded by section 520(o) from the definition of a 
                device under section 201(h), and excluding 
                modifications that are exempt in accordance with 
                section 587A(l)(2)(A); and
                    ``(v) subject to subparagraph (2), a component or 
                part of a test, a test protocol, an instrument, an 
                article, or software described in any of clauses (A) 
                through (D) of such subparagraph, whether alone or in 
                combination, including reagents, calibrators, and 
                controls.
    ``(2) Notwithstanding subparagraph (1)(v), an article intended to 
be used as a component or part of an in vitro clinical test described 
in subparagraph (1) is excluded from the definition in subparagraph (1) 
if the article consists of any of the following:
            ``(A) Blood, blood components, or human cells or tissues, 
        from the time of acquisition, donation, or recovery of such 
        article, including determination of donor eligibility, as 
        applicable, until such time as the article is released as a 
        component or part of an in vitro clinical test by the 
        establishment that collected such article.
            ``(B) An article used for invasive sampling, a needle, or a 
        lancet, except to the extent such article, needle, or lancet is 
        an integral component of an article for holding, storing, or 
        transporting a specimen.
            ``(C) General purpose laboratory equipment, including 
        certain pre-analytical equipment, as determined by the 
        Secretary.
            ``(D) An article used solely for personal protection during 
        the administering, conducting, or otherwise performing of test 
        activities.'';
            (2) by adding at the end of section 201(g) the following:
    ``(3) The term `drug' does not include an in vitro clinical 
test.''; and
            (3) in section 201(h), by striking ``section 520(o)'' and 
        inserting ``section 520(o) or an in vitro clinical test''.
    (b) Exclusion From Definition of Biological Product.--Section 
351(i)(1) of the Public Health Service Act (42 U.S.C. 262(i)(1)) is 
amended--
            (1) by striking ``(1) The term `biological product' means'' 
        and inserting ``(1)(A) The term `biological product' means''; 
        and
            (2) by adding at the end the following:
            ``(B) The term `biological product' does not include an in 
        vitro clinical test as defined in section 201(ss) of the 
        Federal Food, Drug, and Cosmetic Act.''.
    (c) In Vitro Clinical Test Definition.--In this Act, the term ``in 
vitro clinical test'' has the meaning given such term in section 
201(ss) of the Federal Food, Drug, and Cosmetic Act, as added by 
subsection (a).

SEC. 3. REGULATION OF IN VITRO CLINICAL TESTS.

    The Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) is 
amended--
            (1) by amending the heading of chapter V to read as 
        follows: ``DRUGS, DEVICES, AND IN VITRO CLINICAL TESTS''; and
            (2) by adding at the end of chapter V the following:

                ``Subchapter J--In Vitro Clinical Tests

``SEC. 587. DEFINITIONS.

    ``In this subchapter:
            ``(1) Analytical validity.--
                    ``(A) The term `analytical validity' means, with 
                respect to an in vitro clinical test, the ability of 
                the in vitro clinical test, to--
                            ``(i) sufficiently identify, measure, 
                        detect, calculate, or analyze one or more 
                        analytes, biomarkers, substances, or other 
                        targets intended to be identified, measured, 
                        detected, calculated, or analyzed by the test; 
                        or
                            ``(ii) as applicable, assist in such 
                        identification, measurement, detection, 
                        calculation, or analysis.
                    ``(B) For an article for taking or deriving 
                specimens from the human body described in section 
                201(ss)(1)(B)(iii), the term `analytical validity' 
                means that such article performs as intended and will 
                support the analytical validity of an in vitro clinical 
                test with which it is used.
            ``(2) Applicable standard.--The term `applicable standard', 
        with respect to an in vitro clinical test, means a reasonable 
        assurance of analytical and clinical validity, except that such 
        term--
                    ``(A) with respect to test instruments, means a 
                reasonable assurance of analytical validity; and
                    ``(B) with respect to articles for taking or 
                deriving specimens from the human body for purposes 
                described in clause (i) or (ii) of section 
                201(ss)(1)(A) means a reasonable assurance of 
                analytical validity and, where applicable, safety.
            ``(3) Clinical use.--The term `clinical use' means the 
        operation, application, or functioning of an in vitro clinical 
        test in connection with human specimens, including patient, 
        consumer, and donor specimens, for the purpose for which it is 
        intended as described in section 201(ss)(1)(A).
            ``(4) Clinical validity.--The term `clinical validity' 
        means the ability of an in vitro clinical test to achieve the 
        purpose for which it is intended as described in section 
        201(ss)(1)(A).
            ``(5) Cross-referenced test.--The term `cross-referenced 
        test' means an in vitro clinical test that references in its 
        labeling the name or intended use of another medical product 
        that is not an in vitro clinical test.
            ``(6) Develop.--The term `develop', with respect to an in 
        vitro clinical test, means--
                    ``(A) designing, validating, producing, 
                manufacturing, remanufacturing, propagating, or 
                assembling an in vitro clinical test;
                    ``(B) importing an in vitro clinical test;
                    ``(C) modifying an in vitro clinical test initially 
                developed by a different person in a manner that--
                            ``(i) changes any of the listing elements 
                        that define indications for use specified in 
                        paragraph (10), performance claims, or, as 
                        applicable, the safety of such in vitro 
                        clinical test; or
                            ``(ii) affects the analytical or clinical 
                        validity of the in vitro clinical test as 
                        intended by the developer; or
                    ``(D) adopting, using, or disseminating for use as 
                an in vitro clinical test an article not previously 
                intended for clinical use.
            ``(7) Developer.--The term `developer' means a person who 
        engages in an activity described in paragraph (6) for clinical 
        use.
            ``(8) First-of-a-kind.--The term `first-of-a-kind' means, 
        with respect to an in vitro clinical test, a test that has an 
        intended use and a combination of the elements specified in 
        paragraph (10) that differ from the intended use and such 
        elements of other in vitro clinical tests that already are 
        legally available in the United States.
            ``(9) High-risk.--
                    ``(A) In general.--Subject to subparagraph (B), the 
                term `high-risk', with respect to an in vitro clinical 
                test or category of in vitro clinical tests--
                            ``(i) means that, when used as intended by 
                        the developer, an undetected inaccurate result 
                        from such test or category--
                                    ``(I) presents unreasonable risk 
                                for serious or irreversible harm or 
                                death to a patient or patients, or 
                                would otherwise cause serious harm to 
                                the public health; or
                                    ``(II) is potentially likely to 
                                result in the absence, significant 
                                delay, or discontinuation of life-
                                supporting or life-sustaining medical 
                                treatment; and
                            ``(ii) shall account for the degree to 
                        which the technology for the intended use of an 
                        in vitro clinical test or tests is well-
                        characterized and the criteria for performance 
                        of the test or tests are well-established for 
                        the intended use, the clinical circumstances 
                        under which the in vitro clinical test is used, 
                        and the availability of other tests (such as 
                        confirmatory or adjunctive tests).
                    ``(B) Exception.--The term `high-risk' does not 
                include an in vitro clinical test described in 
                subparagraph (A) if--
                            ``(i) mitigating measures are established 
                        to prevent, detect, or otherwise mitigate the 
                        risk of inaccurate results as described in 
                        subparagraph (A), or
                            ``(ii) an exemption from the definition of 
                        such term applies under section 587A.
            ``(10) Indications for use.--The term `indications for use' 
        means one or more in vitro clinical tests that have all of the 
        following notification elements in common:
                    ``(A) Substance or substances measured by the in 
                vitro clinical test, such as an analyte, protein, or 
                pathogen.
                    ``(B) Test method.
                    ``(C) Test purpose or purposes, as described in 
                section 201(ss)(1)(A).
                    ``(D) Diseases or conditions for which the in vitro 
                clinical test is intended for use, including intended 
                patient populations.
                    ``(E) Context of use, such as in a clinical 
                laboratory, in a health care facility, prescription 
                home use, over-the-counter use, or direct-to-consumer 
                testing.
            ``(11) Instrument.--The term `instrument' means an in vitro 
        clinical test that is hardware intended by the hardware's 
        developer to be used with one or more in vitro clinical tests 
        to generate a clinical test result, including software used to 
        effectuate the hardware's functionality.
            ``(12) Instrument family.--The term `instrument family' 
        means more than one instrument for which the developer 
        demonstrates and documents, with respect to all such 
        instruments, that all--
                    ``(A) have the same basic architecture, design, and 
                performance characteristics, such as tolerance limits 
                and signal range;
                    ``(B) have the same intended use or uses and 
                function;
                    ``(C) share the same measurement principles, 
                detection methods, and reaction conditions; and
                    ``(D) produce the same or similar analytical 
                results from samples of the same specimen type or 
                types.
            ``(13) Laboratory operations.--The term `laboratory 
        operations'--
                    ``(A) means the conduct of a laboratory examination 
                or other laboratory procedure on materials derived from 
                the human body, including the conduct of an in vitro 
                clinical test and associated activities within or under 
                the oversight of a laboratory and not related to the 
                design of an in vitro clinical test; and
                    ``(B) includes--
                            ``(i) performing pre-analytical and post-
                        analytical processes for an in vitro clinical 
                        test;
                            ``(ii) conducting standard operating 
                        procedures; and
                            ``(iii) preparing reagents or other test 
                        materials that do not meet the definition of a 
                        in vitro clinical test for clinical use under 
                        section 201(ss).
            ``(14) Low-risk.--The term `low-risk', with respect to an 
        in vitro clinical test or category of in vitro clinical tests, 
        means that an undetected inaccurate result from such in vitro 
        clinical test, or such category of in vitro clinical tests, 
        when used as intended by the developer--
                    ``(A) would cause minimal or no harm, or minimal or 
                no disability, or immediately reversible harm, or would 
                lead to only a remote risk of adverse patient impact or 
                adverse public health impact, taking into account the 
                degree to which the technology for the intended use of 
                an in vitro clinical test or category of tests is well-
                characterized and the criteria for performance of the 
                test or category of tests are well-established for the 
                intended use, the clinical circumstances under which 
                the in vitro clinical test or category of tests is 
                used, and the availability of other tests (such as 
                confirmatory or adjunctive tests); or
                    ``(B) would cause a serious adverse health 
                consequence, harm that is reversible, a delay in 
                necessary treatment that is not life-supporting or 
                life-sustaining, or would lead to a serious risk of 
                adverse patient experience or adverse public health 
                impact, but applied mitigating measures have the 
                capacity to ensure the test meets the standard 
                described in subparagraph (A).
            ``(15) Mitigating measures.--The term `mitigating 
        measures'--
                    ``(A) means controls, standards, or requirements 
                that the Secretary determines, based on available 
                evidence--
                            ``(i) are necessary for an in vitro 
                        clinical test, or a category of in vitro 
                        clinical tests, to meet the applicable 
                        standard; or
                            ``(ii) to mitigate the risk of harm ensuing 
                        from an inaccurate result such that a test or 
                        category of tests subject to such mitigating 
                        measures does not meet the definition of high 
                        risk, or such that a test or category of tests 
                        subject to such mitigating measures is low 
                        risk; and
                    ``(B) includes, as appropriate, applicable 
                requirements regarding labeling, conformance to 
                performance standards or guidance, performance testing, 
                submission of clinical data, advertising, website 
                posting of information, clinical studies, postmarket 
                surveillance, user comprehension studies, training, and 
                availability of confirmatory laboratory or clinical 
                findings.
            ``(16) Specimen receptacle.--The term `specimen receptacle' 
        means an in vitro clinical test specifically intended for the 
        holding, storing, or transporting of specimens derived from the 
        human body or for in vitro examination for purposes described 
        in clause (i) or (ii) of section 201(ss)(1)(A).
            ``(17) Technology.--The term `technology'--
                    ``(A) means a developer's grouping of in vitro 
                clinical tests that do not significantly differ in 
                control mechanisms, energy sources, or operating 
                principals and for which design, development, and 
                manufacturing, including analytical and clinical 
                validation as applicable, of the tests would be 
                addressed in a similar manner or through similar 
                procedures; and
                    ``(B) may include clot detection, colorimetric 
                (non-immunoassay), electrochemical (non-immunoassay), 
                enzymatic (non-immunoassay), flow cytometry, 
                fluorometry (non-immunoassay), immunoassay, mass 
                spectrometry or chromatography (such as HPLC), 
                microbial culture, next generation sequencing (also 
                known as `NGS'), nephlometric or turbidimetric (non-
                immunoassay), singleplex or multiplex non-NGS nucleic 
                acid analysis, single-based technology, spectroscopy, 
                and any other technology, as the Secretary determines 
                appropriate.
            ``(18) Test.--The term `test', unless otherwise provided, 
        means an in vitro clinical test.
            ``(19) Valid scientific evidence.--The term `valid 
        scientific evidence'--
                    ``(A) means, with respect to an in vitro clinical 
                test, evidence--
                            ``(i) that has been generated and evaluated 
                        by persons qualified by training or experience 
                        to do so, using procedures generally accepted 
                        by other persons so qualified; and
                            ``(ii) from which it can be fairly and 
                        responsibly concluded by qualified experts 
                        whether the applicable standard has been met by 
                        the in vitro clinical test for its intended 
                        use; and
                    ``(B) may include evidence described in 
                subparagraph (A) consisting of--
                            ``(i) peer-reviewed literature;
                            ``(ii) clinical guidelines;
                            ``(iii) reports of significant human 
                        experience with an in vitro clinical test;
                            ``(iv) bench studies;
                            ``(v) case studies or histories;
                            ``(vi) clinical data;
                            ``(vii) consensus standards;
                            ``(viii) reference standards;
                            ``(ix) data registries;
                            ``(x) postmarket data;
                            ``(xi) real world data;
                            ``(xii) clinical trials; and
                            ``(xiii) data collected in countries other 
                        than the United States if such data are 
                        demonstrated to be adequate for the purpose of 
                        making a regulatory determination under the 
                        applicable standard in the United States.
            ``(20) Well-characterized.--The term `well-characterized', 
        with respect to an in vitro clinical test, means well-
        established and well-recognized by the scientific or clinical 
        community, if adequately evidenced by one or more of the 
        following:
                    ``(A) Peer-reviewed literature.
                    ``(B) Practice guidelines.
                    ``(C) Consensus standards.
                    ``(D) Recognized standards of care.
                    ``(E) Technology in use for many years.
                    ``(F) Scientific publication by multiple sites.
                    ``(G) Adoption by the scientific or clinical 
                community.
                    ``(H) Real world data.

``SEC. 587A. APPLICABILITY.

    ``(a) In General.--
            ``(1) Applicability of this subchapter.--
                    ``(A) In general.--An in vitro clinical test shall 
                be subject to the requirements of this subchapter, 
                except as otherwise provided this subchapter.
                    ``(B) Interstate commerce.--Any in vitro clinical 
                test that is offered for clinical use in the United 
                States is deemed to be introduced into interstate 
                commerce for purposes of enforcing the requirements of 
                this Act.
                    ``(C) Non-applicable requirement.--Subject to any 
                exemption or exclusion in this section, an in vitro 
                clinical test shall not be subject to any provision or 
                requirement of this Act other than this subchapter 
                unless such other provision or requirement--
                            ``(i) applies expressly to in vitro 
                        clinical tests; or
                            ``(ii) describes the authority of the 
                        Secretary when regulating such in vitro 
                        clinical tests or subset of in vitro clinical 
                        tests, with respect to--
                                    ``(I) all articles regulated by the 
                                Secretary pursuant to this Act; or
                                    ``(II) a subset of such articles 
                                that includes in vitro clinical tests.
            ``(2) Laboratories and blood and tissue establishments.--
                    ``(A) Relation to laboratory certification pursuant 
                to section 353 of the phsa.--Nothing in this subchapter 
                shall be construed to modify the authority of the 
                Secretary with respect to laboratories or clinical 
                laboratories under section 353 of the Public Health 
                Service Act.
                    ``(B) Avoiding duplication.--In implementing this 
                subchapter, the Secretary shall avoid issuing or 
                enforcing regulations that are duplicative of 
                regulations under section 353.
                    ``(C) Blood and tissue.--Nothing in this subchapter 
                shall be construed to modify the authority of the 
                Secretary with respect to laboratories, establishments, 
                or other facilities to the extent they are engaged in 
                the propagation, manufacture, or preparation, including 
                filling, testing, labeling, packaging, and storage, of 
                blood, blood components, human cells, tissues, or 
                tissue products under this Act or section 351 or 361 of 
                the Public Health Service Act.
            ``(3) Practice of medicine.--
                    ``(A) In general.--Nothing in this subchapter shall 
                be construed to limit or interfere with the authority 
                of a health care practitioner to prescribe or 
                administer any legally marketed in vitro clinical test 
                for any condition or disease within a health care 
                practitioner-patient relationship pursuant to 
                applicable Federal or State law.
                    ``(B) Rules of construction.--
                            ``(i) Sale, distribution, labeling.--
                        Nothing in this paragraph shall be construed to 
                        limit the authority of the Secretary to 
                        establish or enforce restrictions on the sale, 
                        distribution, or labeling of an in vitro 
                        clinical test under this Act.
                            ``(ii) Promotion of unapproved uses.--
                        Nothing in this paragraph shall be construed to 
                        alter any prohibition on the promotion of 
                        unapproved uses of legally marketed in vitro 
                        clinical tests.
            ``(4) Special rule.--
                    ``(A) Premarket review applicable.--Notwithstanding 
                the exemptions from premarket review under section 587B 
                set forth in subsections (b), (c), (d), (e), (f), (g), 
                (h), (j), and (k) of such section, an in vitro clinical 
                test (including any article for taking or deriving 
                specimens) shall be subject to the requirements of 
                section 587B if the Secretary determines, in accordance 
                with subparagraph (B), that--
                            ``(i)(I) there is insufficient valid 
                        scientific evidence to support the analytical 
                        validity or the clinical validity of such in 
                        vitro clinical test; and
                            ``(II) such in vitro clinical test is being 
                        offered by its developer with materially 
                        deceptive or fraudulent analytical or clinical 
                        claims;
                            ``(ii) it is reasonably possible that such 
                        in vitro clinical test will cause serious 
                        adverse health consequences; or
                            ``(iii) in the case of specimen 
                        receptacles, there is sufficient valid 
                        scientific evidence indicating that a specimen 
                        receptacle did not perform as intended, will 
                        not support the analytical validity of tests 
                        with which it is used, or as applicable, is not 
                        safe for use.
                    ``(B) Process.--
                            ``(i) Request for information.--If the 
                        Secretary has valid scientific evidence 
                        indicating that the criteria listed in 
                        subparagraph (A) apply to an in vitro clinical 
                        test, the Secretary may request that the 
                        developer of the test submit information--
                                    ``(I) pertaining to such criteria; 
                                and
                                    ``(II) establishing the basis for 
                                any claimed exemption from premarket 
                                review.
                            ``(ii) Deadline for submitting 
                        information.--The developer of an in vitro 
                        clinical test shall submit the information 
                        requested pursuant to clause (i) within 30 days 
                        of receipt of such request.
                            ``(iii) Review deadline.--Upon receiving a 
                        submission under clause (ii), the Secretary 
                        shall--
                                    ``(I) review the submitted 
                                information within 60 calendar days of 
                                such receipt; and
                                    ``(II) determine whether the 
                                criteria listed in subparagraph (A) 
                                apply to the in vitro clinical test.
                            ``(iv) Premarket review required.--
                                    ``(I) In general.--If the Secretary 
                                finds that the criteria listed in 
                                subparagraph (A) apply to the in vitro 
                                clinical test, the developer shall--
                                            ``(aa) promptly, and not 
                                        later than 90 days after the 
                                        date of receipt of such 
                                        information, submit an 
                                        application for premarket 
                                        review of the test under 
                                        section 587B; or
                                            ``(bb) cease to market the 
                                        test.
                                    ``(II) Extension.--The Secretary 
                                may grant an extension to a developer 
                                of the 90-day time period under 
                                subclause (I)(aa), as appropriate.
                            ``(v) Continued marketing.--During the 
                        period beginning on the date of a request for 
                        information under clause (ii) and ending on the 
                        date of the disposition of an application for 
                        premarket review of the in vitro clinical test 
                        under section 587B, the developer of the test 
                        may continue to market the test for clinical 
                        use, unless the Secretary issues an order to 
                        the developer under clause (vi) to immediately 
                        cease distribution of the test.
                            ``(vi) Order to cease distribution.--
                                    ``(I) In general.--If the developer 
                                of an in vitro clinical test fails to 
                                submit an application for premarket 
                                review of the test by the deadline 
                                applicable under clause (iv), or the 
                                Secretary finds that the criteria 
                                listed in subparagraph (A) apply to an 
                                in vitro clinical test and that it is 
                                in the best interest of the public 
                                health, the Secretary may issue an 
                                order, within 10 calendar days of the 
                                applicable deadline or finding by the 
                                Secretary, requiring the developer of 
                                such in vitro clinical test, and any 
                                other appropriate person (including a 
                                distributor or retailer of the in vitro 
                                clinical test) to immediately--
                                            ``(aa) cease distribution 
                                        of the test pending approval of 
                                        an application for premarket 
                                        review of the test under 
                                        section 587B; and
                                            ``(bb) notify health 
                                        professionals and other user 
                                        facilities of the order to 
                                        cease distribution and advise 
                                        health care professionals to 
                                        cease use of such in vitro 
                                        clinical test.
                                    ``(II) Hearing and review.--An 
                                order under subclause (I) shall provide 
                                the person subject to the order with an 
                                opportunity for an informal hearing, to 
                                be held not later than 10 days after 
                                the date of the issuance of the order, 
                                on the actions required by the order 
                                and on whether the order should be 
                                amended to require a recall of such in 
                                vitro clinical test. If, after 
                                providing an opportunity for such a 
                                hearing, the Secretary determines that 
                                inadequate grounds exist to support the 
                                actions required by the order, the 
                                Secretary shall terminate the order 
                                within 30 days of the hearing. Upon 
                                terminating an order, the Secretary 
                                shall provide written notice of such 
                                termination to the developer.
                            ``(vii) Amendment to require recall.--If 
                        the Secretary determines that an order issued 
                        under clause (vi) should be amended to include 
                        a recall of the in vitro clinical test with 
                        respect to which the order was issued, the 
                        Secretary shall amend the order to require a 
                        recall. In such amended order, the Secretary 
                        shall specify a timeframe in which the in vitro 
                        clinical test recall will occur and shall 
                        require periodic reports to the Secretary 
                        describing the progress of the recall. Upon 
                        termination of the recall, the Secretary shall 
                        provide written notice of such termination to 
                        the developer.
                            ``(viii) Effect of test approval.--Any 
                        order issued under this paragraph with respect 
                        to an in vitro clinical test shall cease to be 
                        in effect if such test is granted approval 
                        under section 587B, provided that the in vitro 
                        clinical test is developed and offered for 
                        clinical use in accordance with such approval.
            ``(5) Emergency use.--
                    ``(A) In general.--In the case of a determination 
                under section 319(a) of the Public Health Service Act 
                or a declaration under section 564(b) of this Act, an 
                in vitro clinical test is exempt from the requirements 
                of this subchapter and may be lawfully marketed in 
                accordance with subparagraph (B).
                    ``(B) Criteria.--An in vitro clinical test is 
                exempt from the requirements of this subchapter and may 
                be lawfully marketed in accordance with the exemption 
                described in subparagraph (A) if--
                            ``(i) such test--
                                    ``(I) is submitted for emergency 
                                use authorization under section 564(b); 
                                or
                                    ``(II) is developed and used in 
                                laboratories for which a certificate is 
                                in effect under section 353 of the 
                                Public Health Service Act to conduct 
                                high-complexity testing and the 
                                developer; and
                            ``(ii) the developer--
                                    ``(I) validates such in vitro 
                                clinical test prior to use;
                                    ``(II) notifies the Secretary of 
                                the assay validation; and
                                    ``(III) submits an emergency use 
                                authorization application under section 
                                564 within 15 calendar days of 
                                marketing the test.
                    ``(C) Disposition of product.--With respect to a 
                previously unapproved in vitro clinical test or an in 
                vitro clinical test with an unapproved use, for which 
                an emergency use authorization under section 564(b) 
                ceases to be effective, the Secretary shall consult 
                with the manufacturer of such product with respect to 
                the appropriate disposition of the product.
                    ``(D) Streamlining of application review.--A 
                developer may include any data or information already 
                submitted to the Secretary within the emergency use 
                authorization as a part of a premarket application 
                under section 587B or a technology certification 
                application under section 587D.
            ``(6) Effect on other laws.--Any in vitro clinical test 
        that is lawfully marketed under this Act, including tests that 
        are approved under section 587B, cleared pursuant to an active 
        technology certification order under section 587D, or exempt 
        from premarket review under an exemption in this section, shall 
        be eligible for introduction into interstate commerce except as 
        otherwise provided in this subchapter.
    ``(b) Components and Parts.--
            ``(1) Exemption.--
                    ``(A) In general.--Subject to subparagraph (B), a 
                component, part, or raw material described in section 
                201(ss)(1)(B)(v) is exempt from the requirements of 
                this subchapter if it is--
                            ``(i) intended for further development as 
                        described in paragraph (2); or
                            ``(ii) otherwise to be regulated based on 
                        its risk when used as intended by the 
                        developer, notwithstanding its subsequent use 
                        by a developer as a component, part, or raw 
                        material of another in vitro clinical test.
                    ``(B) Inapplicability to other tests.--
                Notwithstanding subparagraph (A), an in vitro clinical 
                test that is described in section 201(ss)(1)(B) and 
                that uses a component or part described in such 
                subparagraph shall be subject to the requirements of 
                this subchapter, unless the test is otherwise exempt 
                under this section.
            ``(2) Further development.--A component, part, or raw 
        material (as described in paragraph (1)(A)) is intended for 
        further development (for purposes of such paragraph) if--
                    ``(A) it is intended solely for use in the 
                development of another in vitro clinical test; and
                    ``(B) in the case of such a test that is introduced 
                or delivered for introduction into interstate commerce 
                after the date of enactment of the Verifying Accurate 
                Leading-edge IVCT Development Act of 2021, the labeling 
                of such test bears the following statement: `This 
                product is intended solely for further development of 
                an in vitro clinical test and is exempt from FDA 
                regulation. This product must be evaluated by the in 
                vitro clinical test developer if it is used with or in 
                the development of an in vitro clinical test.'.
    ``(c) Grandfathered Tests.--
            ``(1) Exemption.--An in vitro clinical test that meets the 
        criteria set forth in paragraph (2) is exempt from the 
        requirements of this subchapter, except as provided under 
        subsection (a)(4), the registration and listing requirements 
        under section 587I, and the adverse reporting requirements 
        under section 587L, and may be lawfully marketed subject to the 
        other applicable requirements of this Act, if--
                    ``(A) each test report template for the test bears 
                a statement of adequate prominence that reads as 
                follows: `This in vitro clinical test was developed and 
                first introduced prior to the date of enactment of the 
                Verifying Accurate Leading-edge IVCT Development Act of 
                2021 and has not been reviewed by the Food and Drug 
                Administration.'; and
                    ``(B) the developer of the test--
                            ``(i) maintains documentation demonstrating 
                        that the test meets and continues to meet the 
                        criteria set forth in paragraph (2); and
                            ``(ii) makes such documentation available 
                        to the Secretary upon request.
            ``(2) Criteria for exemption.--An in vitro clinical test is 
        exempt as specified in paragraph (1) if the test--
                    ``(A)(i) was first offered for clinical use by such 
                laboratory before the date of enactment of the 
                Verifying Accurate Leading-edge IVCT Development Act of 
                2021;
                    ``(ii) was developed by a clinical laboratory for 
                which a certificate was in effect under section 353 of 
                the Public Health Service Act that meets the 
                requirements under such section 353 for performing 
                high-complexity testing; and
                    ``(iii) is performed--
                            ``(I) in the same clinical laboratory in 
                        which it was developed;
                            ``(II) by another clinical laboratory for 
                        which a certificate is in effect under section 
                        353 within the same corporate organization and 
                        having common ownership by the same parent 
                        corporation; or
                            ``(III) by a laboratory within a public 
                        health laboratory network coordinated or 
                        managed by the Centers for Disease Control and 
                        Prevention;
                    ``(B) does not have in effect an approval under 
                section 515, a clearance under section 510(k), an 
                authorization under section 513(f)(2), or an exemption 
                under section 520(m); and
                    ``(C) is not modified on or after the date of 
                enactment of the Verifying Accurate Leading-edge IVCT 
                Development Act of 2021 by its initial developer (or 
                another person) in a manner such that the test is a new 
                in vitro clinical test under subsection (l).
            ``(3) Modifications.--In the case of a modification to an 
        in vitro clinical test that is exempt as specified in paragraph 
        (1) or such modification is otherwise not subject to premarket 
        review pursuant to section 587A(l), the test continues to 
        qualify for such exemption if the person modifying such test--
                    ``(A) documents each such modification and 
                maintains a summary of the basis for such 
                determination; and
                    ``(B) provides such documentation and summary to 
                the Secretary upon request or inspection.
    ``(d) Tests Exempt From Section 510(k).--
            ``(1) Exemption.--An in vitro clinical test is exempt from 
        premarket review under section 587B and may be lawfully 
        marketed subject to the other applicable requirements of this 
        Act, if the in vitro clinical test--
                    ``(A)(i) was offered for clinical use prior to the 
                date of enactment of the Verifying Accurate Leading-
                edge IVCT Development Act of 2021; and
                    ``(ii) immediately prior to such date of enactment 
                was exempt pursuant to subsection (l) or (m)(2) of 
                section 510 from the requirements for submission of a 
                report under section 510(k); or
                    ``(B)(i) was not offered for clinical use prior to 
                such date of enactment;
                    ``(ii) is not a test platform; and
                    ``(iii) falls within a category of tests that was 
                exempt from the requirements for submission of a report 
                under section 510(k) as of such date of enactment 
                (including class II devices and excluding class I 
                devices described in section 510(l)).
            ``(2) Effect on special controls.--For any in vitro 
        clinical test, or category of in vitro clinical tests, that is 
        exempt from premarket review based on the criteria in paragraph 
        (2), any special control that applied to a device within a 
        predecessor category immediately prior to the date of enactment 
        of Verifying Accurate Leading-edge IVCT Development Act of 2021 
        shall be deemed a mitigating measure applicable under section 
        587E to an in vitro clinical test within the successor 
        category, except to the extent such mitigating measure is 
        withdrawn or changed in accordance with section 587E.
            ``(3) Near-patient testing.--Not later than 1 year after 
        the date of enactment of the Verifying Accurate Leading-edge 
        IVCT Development Act of 2021, the Secretary shall issue draft 
        guidance indicating categories of tests that shall be exempt 
        from premarket review under section 587B when offered for near-
        patient testing (point of care), which were not exempt from 
        submission of a report under section 510(k) pursuant to 
        subsection (l) or (m)(2) of section 510 and regulations 
        imposing limitations on exemption for in vitro devices intended 
        for near-patient testing (point of care).
    ``(e) Low-Risk Tests.--
            ``(1) Exemption.--An in vitro clinical test is exempt from 
        premarket review under section 587B and may be lawfully 
        marketed subject to the other applicable requirements of this 
        Act, including section 587I(b)(6), if such test meets the 
        definition of low-risk under section 587.
            ``(2) List of low-risk tests.--
                    ``(A) In general.--The Secretary shall maintain, 
                and make publicly available on the website of the Food 
                and Drug Administration, a list of in vitro clinical 
                tests, and categories of in vitro clinical tests, that 
                are low-risk in vitro clinical tests for purposes of 
                the exemption under this subsection.
                    ``(B) Inclusion.--The list under subparagraph (A) 
                shall consist of--
                            ``(i) all in vitro clinical tests and 
                        categories of in vitro clinical tests that are 
                        exempt from premarket review pursuant to 
                        subsection (d)(1) or (d)(3); and
                            ``(ii) all in vitro clinical tests and 
                        categories of in vitro clinical tests that are 
                        designated by the Secretary pursuant to 
                        subparagraph (C) as low-risk for purposes of 
                        this subsection.
                    ``(C) Designation of tests and categories.--Without 
                regard to subchapter II of chapter 5 of title 5, United 
                States Code, the Secretary may designate, in addition 
                to the tests and categories described in subparagraph 
                (B)(i), additional in vitro clinical tests, and 
                categories of in vitro clinical tests, as low-risk in 
                vitro clinical tests for purposes of the exemption 
                under this subsection. The Secretary may make such a 
                designation on the Secretary's own initiative or in 
                response to a request by any person. In making such a 
                designation for a test or category of tests, the 
                Secretary shall consider--
                            ``(i) whether the test, or category of 
                        tests, is low-risk; and
                            ``(ii) such other factors as the Secretary 
                        determines to be relevant to the protection of 
                        the public health.
    ``(f) Manual Tests.--
            ``(1) Exemption.--An in vitro clinical test is exempt from 
        all requirements of this subchapter if the output of such in 
        vitro clinical test is the result of direct, manual 
        observation, without the use of automated instrumentation or 
        software for intermediate or final interpretation, by a 
        qualified laboratory professional, and such in vitro clinical 
        test--
                    ``(A) is designed, manufactured, and used within a 
                single clinical laboratory for which a certificate is 
                in effect under section 353 of the Public Health 
                Service Act that meets the requirements under section 
                353 for performing high-complexity testing;
                    ``(B) is not a high-risk test, or is a high-risk 
                test that the Secretary has determined meets at least 
                one condition in paragraph (2) and is otherwise 
                appropriate for this exemption; and
                    ``(C) is not intended for testing donors, 
                donations, and recipients of blood, blood components, 
                human cells, tissues, cellular-based products, or 
                tissue-based products.
            ``(2) High-risk test limitation or condition.--A high-risk 
        test may be exempt under paragraph (1) from the requirements of 
        this subchapter only if--
                    ``(A) no component or part of such test, including 
                any reagent, is introduced into interstate commerce 
                under the exemption under subsection (b)(1) (relating 
                to components or parts intended for further 
                development), and any article for taking or deriving 
                specimens from the human body used in conjunction with 
                the test remains subject to the requirements of this 
                subchapter; or
                    ``(B) the test has been developed in accordance 
                with the applicable test design and quality 
                requirements under section 587J.
    ``(g) Humanitarian Test Exemption.--
            ``(1) In general.--An in vitro clinical test is exempt from 
        premarket review under section 587B and may be lawfully 
        marketed subject to the other applicable requirements of this 
        Act, if--
                    ``(A) such in vitro clinical test is intended for 
                use for a disease or condition for which no more than 
                10,000 (or such other number determined by the 
                Secretary) individuals would be subject to negative or 
                positive diagnosis by such test in the United States 
                per year; and
                    ``(B) the developer of the test--
                            ``(i) maintains documentation (which may 
                        include literature citations in specialized 
                        medical journals, textbooks, specialized 
                        medical society proceedings, governmental 
                        statistics publications, or, if no such studies 
                        or literature citations exist, credible 
                        conclusions from appropriate research or 
                        surveys) demonstrating that such test meets and 
                        continues to meet the criteria described in 
                        this paragraph; and
                            ``(ii) makes such documentation available 
                        to the Secretary upon request.
            ``(2) Cross-referenced tests.--In order to be eligible for 
        an exemption under this subsection, the developer of a cross-
        referenced test shall submit a request under section 587H for 
        informal feedback.
    ``(h) Custom Tests and Low-Volume Tests.--An in vitro clinical test 
is exempt from premarket review under section 587B, the quality 
requirements under section 587J, and the notification requirements 
under section 587I, and may be lawfully marketed subject to the other 
applicable requirements of this Act, if--
            ``(1) such in vitro clinical test--
                    ``(A) is a low-volume test performed in a 
                laboratory in which it was developed or developed in a 
                laboratory within the same corporate organization with 
                the laboratory in which such test is performed and is 
                administered to no more than 5 patients per year, 
                unless otherwise determined by the Secretary; or
                    ``(B) is a custom test developed or modified to 
                diagnose a unique pathology or physical condition of a 
                specific patient for which no other in vitro clinical 
                test is commercially available in the United States, 
                and is--
                            ``(i) not intended for use with respect to 
                        other patients; and
                            ``(ii) after the development of the custom 
                        test, not included in any test menu, template 
                        test report, or other promotional materials, 
                        and not otherwise advertised; and
            ``(2) the developer of the test--
                    ``(A) maintains documentation demonstrating that 
                such test meets and continues to meet the applicable 
                criteria described in paragraph (1);
                    ``(B) makes such documentation, such as a 
                prescription order requesting the custom test for an 
                individual patient, available to the Secretary upon 
                request; and
                    ``(C) informs the Secretary, on an annual basis, in 
                a manner prescribed by the Secretary by guidance, that 
                such test was introduced into interstate commerce.
    ``(i) Public Health Surveillance Activities.--
            ``(1) In general.--The provisions of this subchapter shall 
        not apply to a test intended by the developer to be used solely 
        for public health surveillance activities, including the 
        collection and testing of information or biospecimens, 
        conducted, supported, requested, ordered, required, or 
        authorized by a public health authority.
            ``(2) Limitation.--The public health surveillance 
        activities described in paragraph (1)--
                    ``(A) are limited to activities necessary to allow 
                a public health authority to identify, monitor, assess, 
                or investigate potential public health signals, onsets 
                of disease outbreaks, or conditions of public health 
                importance (including trends, risk factors, patterns in 
                diseases, and increases in injuries from using consumer 
                products); and
                    ``(B) include activities associated with providing 
                timely situational awareness and priority setting 
                during the course of a threat to the public health 
                (including natural or man-made disasters and deliberate 
                attacks on the United States).
            ``(3) Exclusion.--An in vitro clinical test is not excluded 
        from the provisions of this subchapter if such test is intended 
        for use in making clinical decisions for individual patients.
    ``(j) Law Enforcement or Employer Testing.--An in vitro clinical 
test that is intended solely for use in forensic analysis, law 
enforcement activity, or employment purposes is exempt from the 
requirements of this Act. An in vitro clinical test that is intended 
for use in making clinical decisions for individual patients, or whose 
individually identifiable results may be reported back to an individual 
patient or the patient's health care provider, even if also intended 
for law enforcement or employment testing purposes, is not intended 
solely for use in law enforcement or employment testing for purposes of 
this subsection.
    ``(k) In Vitro Clinical Tests Under a Technology Certification 
Order.--An in vitro clinical test that is within the scope of a 
technology certification order, as described in section 587D(a), is 
exempt from premarket review under section 587B.
    ``(l) Modified Tests.--
            ``(1) In general.--An in vitro clinical test that is 
        modified, by the initial developer of the test or a different 
        person, is a new in vitro clinical test subject to the 
        requirements of this subchapter if the modification--
                    ``(A) affects the analytical or clinical validity 
                of such test;
                    ``(B) causes the test to no longer comply with 
                applicable mitigating measures under section 587E or 
                restrictions under section 587N; or
                    ``(C) as applicable, affects the safety of an 
                article for taking or deriving specimens from the human 
                body for a purpose described in section 201(ss)(1).
            ``(2) Exemptions.--Notwithstanding paragraph (1), an in 
        vitro clinical test that is modified by the initial developer 
        of the test or a different person is not a new in vitro 
        clinical test if the modification--
                    ``(A) is a software update that does not have an 
                adverse effect on the analytical or clinical validity 
                or result in an increased risk to patients and 
                consumers;
                    ``(B) is made pursuant to methods or criteria 
                included in the change protocol premarket submission, 
                amendment, or supplement approved by the Secretary for 
                the in vitro clinical test being modified;
                    ``(C) is a labeling change that is appropriate to 
                address patient or user harm; or
                    ``(D) is a specimen-related modification that--
                            ``(i) is made to extend specimen stability; 
                        or
                            ``(ii) aligns with the data and information 
                        submitted in an approved application for 
                        premarket review under section 587B or a 
                        technology certification order issued under 
                        section 587D.
            ``(3) Documentation.--When a person modifies an in vitro 
        clinical test that was developed by another person, such 
        modified test is exempt from the requirements of this 
        subchapter provided that such person--
                    ``(A) documents the modification that was made and 
                the basis for determining that the modification, 
                considering the changes individually and collectively, 
                was not a type of modification described in paragraph 
                (1); and
                    ``(B) provides such documentation to the Secretary 
                upon request or inspection.
    ``(m) Investigational Use.--An in vitro clinical test for 
investigational use is exempt from the requirements of this Act, except 
as provided in section 587R.
    ``(n) Transfer or Sale of In Vitro Clinical Tests.--
            ``(1) Transfer and assumption of regulatory obligations.--
        If ownership of an in vitro clinical test is sold or 
        transferred in such manner that the developer transfers the 
        regulatory submissions and obligations applicable under this 
        subchapter with respect to the test, the transferee or 
        purchaser becomes the developer of the test and shall have all 
        regulatory obligations applicable to such a test under this 
        subchapter. The transferee or purchaser shall update the 
        registration and listing information under section 587I for the 
        in vitro clinical test.
            ``(2) Transfer or sale of premarket approval.--
                    ``(A) Notice required.--If a developer of an in 
                vitro clinical test transfers or sells the approval of 
                the in vitro clinical test, the transferor or seller 
                shall--
                            ``(i) submit a notice of the transfer or 
                        sale to the Secretary and update the 
                        registration and listing information under 
                        section 587I for the in vitro clinical test; 
                        and
                            ``(ii) submit a supplemental application if 
                        required under section 587B(h).
                    ``(B) Effective date of approval transfer.--A 
                transfer or sale described in subparagraph (A) shall 
                become effective upon completion of a transfer or sale 
                described in paragraph (1) or the approval of a 
                supplemental application under section 587B(h) if 
                required, whichever is later. The transferee or 
                purchaser shall update the registration and listing 
                information under section 587I for the in vitro 
                clinical test within 15 calendar days of the effective 
                date of the transfer or sale.
            ``(3) Transfer or sale of technology certification.--
                    ``(A) Requirements for transfer or sale of 
                technology certification.--An unexpired technology 
                certification can be transferred or sold if the 
                transferee or purchaser--
                            ``(i) is an eligible person under section 
                        587D(b)(1); and
                            ``(ii) maintains, upon such transfer or 
                        sale, the site, test design and quality 
                        requirements, processes and procedures under 
                        the scope of technology certification, and 
                        scope of the technology certification 
                        identified in the applicable technology 
                        certification order.
                    ``(B) Notice required.--If a developer of an in 
                vitro clinical test transfers or sells a technology 
                certification order that has not expired, the 
                transferor or seller shall submit a notice of the 
                transfer or sale to the Secretary and shall update the 
                registration and listing information under section 587I 
                for all in vitro clinical tests covered by the 
                technology certification.
                    ``(C) Effective date of technology certification 
                transfer.--The transfer of a technology certification 
                shall become effective upon completion of a transfer or 
                sale described in subparagraph (A). The transferee or 
                purchaser shall update the registration and listing 
                information under section 587I for the in vitro 
                clinical test within 30 calendar days of the effective 
                date of the technology certification transfer.
                    ``(D) New technology certification required.--If 
                the requirements of subparagraph (A)(ii) are not met, 
                the technology certification order may not be 
                transferred and the transferee or purchaser of an in 
                vitro clinical test is required to submit an 
                application for technology certification and obtain a 
                technology certification order prior to offering the 
                test for clinical use.
    ``(o) General Laboratory Equipment.--Any instrument that does not 
produce an analytical result, and that functions as a component of pre-
analytical procedures related to in vitro clinical tests, is not 
subject to the requirements of this subchapter, provided that--
            ``(1) the instrument is operating in a clinical laboratory 
        that is certified under section 353 of the Public Health 
        Service Act; and
            ``(2) the instrument can be serviced by the manufacturer of 
        such instrument or, if that manufacturer is no longer in 
        business, a third party with the ability to service such 
        instrument.
    ``(p) Instrument Families.--In the case of an instrument family, 
premarket approval under section 587B(d) of one version of the in vitro 
clinical test is required, and previous and updated versions of the 
same test within such instrument family shall be deemed to be subject 
to the approval pursuant to that section, unless the Secretary 
determines otherwise, as set forth in guidance.
    ``(q) General Exemption Authority.--The Secretary may, by order 
published in the Federal Register following notice and an opportunity 
for comment, exempt a class of persons from any section under this 
subchapter upon a finding that such exemption is appropriate for the 
protection of the public health and other relevant considerations.
    ``(r) Regulations.--The Secretary may issue regulations to 
implement this subchapter.

``SEC. 587B. PREMARKET REVIEW.

    ``(a) In General.--No person shall introduce or deliver for 
introduction into interstate commerce any in vitro clinical test, 
unless--
            ``(1) an approval of an application filed pursuant to 
        subsection (c) or (d) is effective with respect to test; or
            ``(2) the test is exempt under section 587A from premarket 
        review under this section.
    ``(b) Transparency and Predictability.--
            ``(1) Pre-submission meeting or request for informal 
        feedback.--Pursuant to section 587H, prior to filing an 
        application under subsection (c) or (d), any person may request 
        a meeting or written correspondence with the Secretary to 
        discuss the eligibility of an in vitro clinical test for 
        premarket review or other information related to the filing of 
        an application. The Secretary shall respond to such request 
        within 45 calendar days.
            ``(2) Streamlining of applications.--
                    ``(A) Premarket application and technology 
                certification.--If a person files a premarket 
                application under this section and provides any 
                additional documentation required under section 587D, 
                the in vitro clinical test that is the subject of the 
                application may be utilized as the representative test 
                reviewed by the Secretary to provide an approval for 
                both a premarket application under this section and a 
                technology certification order under section 587D.
                    ``(B) Representative assays for premarket 
                approval.--With respect to a technology certification 
                application filed under section 587D, the 
                representative test, as described in subparagraph (A), 
                used to issue a technology certification order under 
                section 587D shall be deemed a test with premarket 
                approval under this section.
    ``(c) Application.--
            ``(1) Filing.--Any person may file with the Secretary an 
        application for premarket approval of an in vitro clinical 
        test.
            ``(2) Application content.--An application submitted under 
        paragraph (1) with respect to an in vitro clinical test shall 
        include the following, in such format as the Secretary 
        specifies:
                    ``(A) General information regarding the in vitro 
                clinical test, including--
                            ``(i) the name and address of the 
                        applicant;
                            ``(ii) the table of contents for the 
                        application and the identification of the 
                        information the applicant claims as trade 
                        secret or confidential commercial or financial 
                        information;
                            ``(iii) a description of the test's 
                        intended use;
                            ``(iv) an explanation regarding test 
                        function and any significant performance 
                        characteristics; and
                            ``(v) an explanation of how the development 
                        and validation activities support the test 
                        meeting the applicable standard.
                    ``(B) A summary of the data and information in the 
                application for the in vitro clinical test, including--
                            ``(i) a brief description of any existing 
                        alternative practices or procedures for 
                        diagnosing the disease or condition for which 
                        the in vitro clinical test is intended, as 
                        applicable;
                            ``(ii) a brief description of the foreign 
                        and domestic marketing history of the test, if 
                        any, including a list of all countries in which 
                        the test has been marketed and a list of all 
                        countries in which the test has been withdrawn 
                        from marketing for any reason related to the 
                        applicable standard of the in vitro clinical 
                        test, if known by the applicant;
                            ``(iii) a summary of the any studies 
                        submitted for such test, including a 
                        description of the objective of the study, a 
                        description of the experimental design of the 
                        study, a brief description of how the data were 
                        collected and analyzed, a brief description of 
                        the results of the technical data submitted, 
                        and a brief description of any nonclinical or 
                        clinical studies;
                            ``(iv) a risk assessment of the test; and
                            ``(v) conclusions drawn from any studies 
                        described in clause (iii), including a 
                        discussion demonstrating that the data and 
                        information in the application constitute valid 
                        scientific evidence and meet the applicable 
                        standard under section 587(2), an explanation 
                        of how the development and validation 
                        activities, as applicable, support that the 
                        test meets the applicable standard under 
                        section 587(2), and a discussion of any adverse 
                        effects of the test on health and proposals to 
                        mitigate those risks, if any.
                    ``(C) The signature of the person filing the 
                premarket application or an authorized representative.
                    ``(D) A bibliography of all published reports 
                reasonably known to the applicant related to such test 
                and a discussion of data and information relevant to 
                the evaluation of the applicable standard that may be 
                met by such test.
                    ``(E) A statement that the applicant believes to 
                the best of the applicant's knowledge that all data and 
                information submitted to the Secretary are truthful and 
                accurate and that no material fact has been omitted in 
                the application.
                    ``(F) Except as provided under subsection (d), 
                applicable information regarding the methods used in, 
                or the facilities or controls used for, the development 
                of the test to demonstrate compliance with the 
                applicable quality requirements under section 587J.
                    ``(G) Information demonstrating compliance with any 
                relevant--
                            ``(i) mitigating measures under section 
                        587E; and
                            ``(ii) standards established or recognized 
                        under section 514 prior to the date of 
                        enactment of the Verifying Accurate Leading-
                        edge IVCT Development Act of 2021, or, after 
                        applicable standards are established or 
                        recognized under section 587Q, with such 
                        standards.
                    ``(H) Valid scientific evidence to support 
                analytical and clinical validity of the test, which 
                shall include--
                            ``(i) summary information for all 
                        supporting validation studies performed;
                            ``(ii) raw data, such as tabulations of 
                        data and results as required under section 
                        814.20(b)(6)(ii) of title 21, Code of Federal 
                        Regulations (or any successor regulations);
                            ``(iii) for nonclinical laboratory studies 
                        involving the test, a statement that studies 
                        were conducted in compliance with applicable 
                        good laboratory practices; and
                            ``(iv) for investigations involving human 
                        subjects, statements that any clinical 
                        investigation involving human subjects was 
                        conducted in compliance with applicable--
                                    ``(I) institutional review board 
                                regulations;
                                    ``(II) informed consent 
                                regulations; and
                                    ``(III) investigational use 
                                requirements in section 587R.
                    ``(I) To the extent the application seeks 
                authorization to make modifications to the test within 
                the scope of the approval, a change protocol that 
                includes validation procedures and acceptance criteria 
                for anticipated modifications that could be made to the 
                test within the scope of the approval.
                    ``(J) Proposed labeling, in accordance with the 
                requirements of section 587K.
                    ``(K) Such other data or information as the 
                Secretary may require in accordance with the least 
                burdensome requirements of subsection (j).
            ``(3) Guidance for premarket and special premarket 
        applications.--In accordance with section 5 of the Verifying 
        Accurate Leading-edge IVCT Development Act of 2021, the 
        Secretary shall issue draft guidance detailing the information 
        to be provided in a premarket application and special premarket 
        application under this section. The Secretary shall issue final 
        guidance not later than 90 calendar days after the close of the 
        comment period for such guidance.
            ``(4) Refuse to file a premarket or special premarket 
        application.--If, after receipt of an application under this 
        section, the Secretary refuses to file such application, the 
        Secretary shall provide to the developer, within 60 calendar 
        days of receipt of such application, a description of the 
        reason for such refusal, and identify the information required, 
        if any, to allow for the filing of the application.
            ``(5) Substantive review for deficient application.--If, 
        after receipt of an application under this section, the 
        Secretary determines that any portion of such application is 
        deficient, the Secretary shall provide to the applicant, within 
        75 calendar days of receipt of such application, a description 
        of such deficiencies and identify the information required to 
        correct such deficiencies.
    ``(d) Special Premarket Review.--
            ``(1) In general.--Any person may file with the Secretary 
        an application for special premarket approval for--
                    ``(A) an instrument;
                    ``(B) a specimen receptacle;
                    ``(C) an in vitro clinical test eligible for a 
                technology certification order under section 587D; or
                    ``(D) a first-of-a-kind test (unless it is a high-
                risk test), a direct-to-consumer test, or cross-
                referenced test that does not have mitigating measures.
            ``(2) Application content.--An application under paragraph 
        (1) shall include--
                    ``(A) the information required for applications 
                submitted under subsection (c)(2), except that 
                applications under paragraph (1) need not include--
                            ``(i) quality requirement information; or
                            ``(ii) raw data unless explicitly requested 
                        by the Secretary;
                    ``(B) in the case of a specimen receptacle, safety 
                information; and
                    ``(C) data, as applicable, to support software 
                validation, electromagnetic compatibility, and 
                electrical safety, and information demonstrating 
                compliance with maintaining quality systems 
                documentation.
            ``(3) Inspections.--With respect to an application under 
        paragraph (1), preapproval inspections authorized by an 
        employee of the Food and Drug Administration or a person 
        accredited under section 587P need not occur unless requested 
        by the Secretary.
    ``(e) Instrument Family.--When an in vitro clinical test has been 
approved, or is otherwise legally marketed, for use on a specific 
approved or legally marketed instrument within an instrument family, a 
submission under this section shall not be required for that in vitro 
clinical test in order for it to be used on a new instrument within 
that instrument's family.
    ``(f) Amendments to an Application.--
            ``(1) In general.--An applicant may amend an original or 
        supplemental application under subsection (c) or (d).
            ``(2) Required amendment or supplement.--An applicant shall 
        amend or supplement an application submitted under subsection 
        (c) or (d) if the applicant becomes aware of information that--
                    ``(A) could reasonably affect an evaluation of 
                whether the applicable standard has been met; or
                    ``(B) could reasonably affect the statement of 
                contraindications, warnings, precautions, and adverse 
                reactions in the proposed labeling.
            ``(3) Request for amendment or supplement.--The Secretary 
        may request that an applicant amend or supplement an 
        application under subsection (c) or (d) with any information 
        necessary for review under this section.
    ``(g) Action on an Application for Premarket Approval.--
            ``(1) Review.--
                    ``(A) Disposition.--As promptly as possible, but 
                not later than 90 calendar days after an application 
                under subsection (c) is accepted for submission (unless 
                the Secretary determines that an extension is necessary 
                to review one or more major amendments to the 
                application), or not later than 60 calendar days after 
                an application under subsection (d) is accepted for 
                submission, the Secretary, after considering any 
                applicable report and recommendations pursuant to 
                advisory committees under section 587G, or prior to the 
                establishment of such advisory committees, any 
                recommendations by a classification panel under section 
                513, shall issue an order approving the application, 
                unless the Secretary finds that the grounds for 
                approval in paragraph (2) are not met.
                    ``(B) Reliance on proposed labeling.--In 
                determining whether to approve or deny an application 
                under paragraph (1), the Secretary shall rely on the 
                intended use included in the proposed labeling, 
                provided that such labeling is not false or misleading 
                based on a fair evaluation of all material facts.
            ``(2) Approval of an application.--
                    ``(A) In general.--The Secretary shall approve an 
                application submitted under subsection (c) with respect 
                to an in vitro clinical test if the Secretary finds 
                that there is a reasonable assurance that the 
                applicable standard is met, and--
                            ``(i) except as provided under subsection 
                        (d), the applicant is in compliance with 
                        applicable quality requirements in section 587J 
                        or as otherwise specified in a condition of 
                        approval, or maintains the documentation 
                        required to be in compliance with such 
                        requirements if the applicant is not required 
                        to submit such documentation as a part of the 
                        application under this section;
                            ``(ii) the application does not contain a 
                        false statement of material fact;
                            ``(iii) based on a fair evaluation of all 
                        material facts, the proposed labeling is 
                        truthful and non-misleading and complies with 
                        the requirements of section 587K;
                            ``(iv) except as provided under subsection 
                        (d), the applicant permits, if requested, 
                        authorized employees of the Food and Drug 
                        Administration and persons accredited under 
                        section 587P an opportunity--
                                    ``(I) to inspect at a reasonable 
                                time and in a reasonable manner the 
                                facilities and all pertinent equipment, 
                                finished and unfinished materials, 
                                containers, and labeling therein, 
                                including all things (including 
                                records, files, papers, and controls) 
                                bearing on whether an in vitro clinical 
                                test is adulterated, misbranded, or 
                                otherwise in violation of this Act; and
                                    ``(II) to view and to copy and 
                                verify all records pertinent to the 
                                application and the in vitro clinical 
                                test;
                            ``(v) the test conforms with any applicable 
                        performance standards under section 587Q and 
                        any applicable mitigating measures under 
                        section 587E; and
                            ``(vi) all nonclinical laboratory studies 
                        and clinical investigations involving human 
                        subjects that are described in the application 
                        were conducted in a manner that meets the 
                        requirements of this section.
                    ``(B) Conditions of approval.--An order approving 
                an application pursuant to this paragraph may require 
                conditions of approval for the in vitro clinical test, 
                including conformance with performance standards under 
                section 587Q and restrictions under section 587N.
                    ``(C) First-of-a-kind test.--For a first-of-a-kind 
                in vitro clinical test, an order approving an 
                application pursuant to this paragraph--
                            ``(i) may impose requirements for tests 
                        with the same indications for use, including 
                        conformance with performance standards under 
                        section 587Q and mitigating measures under 
                        section 587E, and comply with restrictions 
                        under section 587N; and
                            ``(ii) shall indicate whether subsequent in 
                        vitro clinical tests with the same intended use 
                        may meet an exemption set forth in section 
                        587A.
                    ``(D) Publication.--The Secretary shall publish 
                each order approving an application pursuant to this 
                paragraph on the public website of the Food and Drug 
                Administration and make publicly available a summary of 
                the data used to grant the approval, except to the 
                extent the Secretary determines that such order--
                            ``(i) contains commercially confidential or 
                        trade secret information; or
                            ``(ii) relates to national security or 
                        countermeasures is restricted from disclosure 
                        pursuant to statutory provisions other than 
                        this section.
            ``(3) Review of denials.--An applicant whose application 
        submitted under subsection (c) or (d) has been denied approval 
        may, by petition filed not more than 60 calendar days after the 
        date on which the applicant receives notice of such denial, 
        obtain review of the denial in accordance with section 587O.
    ``(h) Supplements to an Application.--
            ``(1) Risk analysis.--Prior to implementing any 
        modification to an in vitro clinical test, the holder of the 
        application approved under subsection (c) or (d) for such test 
        shall perform risk analyses in accordance with section 587J, 
        unless such modification is included in the change protocol 
        submitted by the applicant and approved under this section or 
        exempt under section 587A(l).
            ``(2) Supplement requirement.--
                    ``(A) In general.--Except as provided in 
                subparagraph (B), or otherwise specified by the 
                Secretary, the holder of the application approved under 
                subsection (g) for an in vitro clinical test shall 
                submit to the Secretary and receive approval of a 
                supplement before implementing a modification to the 
                test, unless such modification is exempt under section 
                587A(l).
                    ``(B) Adjustments to change protocol.--A person may 
                submit under this paragraph a supplemental application 
                adjusting the change protocol of the test at any time 
                after the initial filing of an application under 
                subsection (c) or (d).
                    ``(C) Exceptions.--Subject to subparagraphs (D) and 
                (E), and so long as the holder of an approved 
                application submitted under subsection (c) or (d) for 
                an in vitro clinical test does not add a manufacturing 
                site, or change activities at an existing manufacturing 
                site, with respect to the test, the holder may, without 
                prior approval of a supplement, implement the following 
                modifications to the test:
                            ``(i) Modifications included in and 
                        implemented in accordance with an approved 
                        change protocol under subsection (c)(2)(I).
                            ``(ii) Modifications that do not change--
                                    ``(I) the analytical or clinical 
                                validity of the test;
                                    ``(II) the intended use of the test 
                                unless provided under an approved 
                                change protocol under subsection 
                                (c)(2)(I); or
                                    ``(III) the safety of the specimen 
                                receptacles.
                            ``(iii) Labeling changes to appropriately 
                        address a safety concern.
                            ``(iv) Modifications that are exempt under 
                        section 587A(l).
                    ``(D) Reporting for change protocol 
                modifications.--As a component of the report required 
                under subsection (k), the holder of an application 
                approved under subsection (g) for an in vitro clinical 
                test shall--
                            ``(i) report any modification to the test 
                        described in clause (i) or (ii) of subparagraph 
                        (C) in the next annual report for the test 
                        under subsection (k) following the date on 
                        which the test, with such modification, is 
                        introduced into interstate commerce; and
                            ``(ii) include in such report--
                                    ``(I) a description of the 
                                modification; and
                                    ``(II) as applicable, a summary of 
                                the analytical validity and clinical 
                                validity of the test, as modified, and 
                                any changes to acceptance criteria.
                    ``(E) Reporting for other category of exceptions.--
                The holder of the application approved under subsection 
                (c) or (d) for an in vitro clinical test shall--
                            ``(i) report to the Secretary any 
                        modification to the test described in clause 
                        (iii) of subparagraph (C) not more than 60 days 
                        after the date on which the test, with the 
                        modification, is introduced into interstate 
                        commerce; and
                            ``(ii) include in the report--
                                    ``(I) a summary of the relevant 
                                change or changes;
                                    ``(II) the rationale for 
                                implementing such change or changes; 
                                and
                                    ``(III) a description of how the 
                                change or changes were evaluated.
                    ``(F) Request for supplement.--Upon review of the 
                information received under subparagraph (D) and a 
                finding that the relevant modification is inconsistent 
                with the standard specified under subparagraph (C), the 
                Secretary may require a supplement under subparagraph 
                (A). If the Secretary determines that a supplement 
                under subparagraph (A) is required, the Secretary shall 
                notify the applicant of such determination. Such 
                notification shall include a justification for the 
                submission of a supplement. Prior to the submission of 
                a supplement under this subparagraph, the applicant may 
                request a meeting or written correspondence to gain 
                agency feedback as to the necessity of such 
                supplemental filing. The Secretary shall respond to 
                such meeting request within 30 calendar days of 
                receipt.
            ``(3) Contents of supplement.--Unless otherwise specified 
        by the Secretary, a supplement under this subsection shall 
        include--
                    ``(A) for modifications other than manufacturing 
                site changes--
                            ``(i) a description of the modification;
                            ``(ii) data to demonstrate that the 
                        applicable standard is met;
                            ``(iii) acceptance criteria; and
                            ``(iv) any revised labeling; and
                    ``(B) for manufacturing site changes--
                            ``(i) the information listed in 
                        subparagraph (A); and
                            ``(ii) information regarding the methods 
                        used in, or the facilities or controls used 
                        for, the development of the test to demonstrate 
                        compliance with the applicable quality 
                        requirements under section 587J.
            ``(4) Additional data.--The Secretary may require, when 
        necessary, data to evaluate a modification to an in vitro 
        clinical test that is in addition to the data otherwise 
        required under the preceding paragraphs if the data request is 
        in accordance with the least burdensome requirements under 
        subsection (j).
            ``(5) Conditions of approval.--In an order approving a 
        supplement under this subsection, the Secretary may require 
        conditions of approval for the in vitro clinical test, 
        including compliance with restrictions under section 587N and 
        conformance to performance standards under section 587Q.
            ``(6) Approval.--The Secretary shall approve a supplement 
        under this subsection if--
                    ``(A) the data demonstrate that the modified in 
                vitro clinical test meets the applicable standard; and
                    ``(B) the holder of the application approved under 
                subsection (g) for the test has demonstrated compliance 
                with applicable quality and inspection requirements, as 
                applicable and appropriate.
            ``(7) Publication.--The Secretary shall publish on the 
        public website of the Food and Drug Administration notice of 
        any order approving a supplement under this subsection, except 
        that such publication shall exclude--
                    ``(A) commercial confidential or trade secret 
                information; and
                    ``(B) any other information that the Secretary 
                determines to relate to national security or 
                countermeasures or to be restricted from disclosure 
                pursuant to another provision of law.
            ``(8) Review of denial.--An applicant whose supplement 
        under this subsection has been denied approval may, by petition 
        filed on or before the 60th calendar day after the date upon 
        which the applicant receives notice of such denial, obtain 
        review of the denial in accordance with section 587O.
    ``(i) Withdrawal and Temporary Suspension of Approval.--
            ``(1) Order withdrawing approval.--
                    ``(A) In general.--The Secretary may, within 10 
                calendar days of providing due notice and an 
                opportunity for an informal hearing to the holder of an 
                approved application for an in vitro clinical test 
                under this section, issue an order withdrawing approval 
                of the application if the Secretary finds that--
                            ``(i) the grounds for approval under 
                        subsection (g) are no longer met; or
                            ``(ii) there is a reasonable likelihood 
                        that the test would cause death or serious 
                        adverse health consequences, including by 
                        causing the absence, delay, or discontinuation 
                        of life-saving or life sustaining medical 
                        treatment.
                    ``(B) Content.--An order under subparagraph (A) 
                withdrawing approval of an application shall state each 
                ground for withdrawal and shall notify the holder of 
                such application 60 calendar days prior to issuing such 
                order.
                    ``(C) Publication.--The Secretary shall publish any 
                order under subparagraph (A) on the public website of 
                the Food and Drug Administration, except that such 
                publication shall exclude--
                            ``(i) commercial confidential or trade 
                        secret information; and
                            ``(ii) any other information that the 
                        Secretary determines to relate to national 
                        security or countermeasures or to be restricted 
                        from disclosure pursuant to another provision 
                        of law.
            ``(2) Order of temporary suspension.--If, after providing 
        due notice and an opportunity for an informal hearing to the 
        holder of an approved application for an in vitro clinical test 
        under this section, the Secretary determines there is a 
        reasonable likelihood that the in vitro clinical test would 
        cause death or serious adverse health consequences, including 
        by causing the absence, delay, or discontinuation of life-
        saving or life-sustaining medical treatment, the Secretary 
        shall by order temporarily suspend the approval of the 
        application. If the Secretary issues such an order, the 
        Secretary shall proceed expeditiously under paragraph (1) to 
        withdraw approval of such application.
    ``(j) Least Burdensome Requirements.--
            ``(1) In general.--In carrying out this subchapter, the 
        Secretary shall consider the least burdensome means necessary 
        to provide a reasonable assurance of analytical and clinical 
        validity, or applicable standard, and other regulatory 
        requirements, as determined by the Secretary.
            ``(2) Necessary defined.--For purposes of paragraph (1) and 
        paragraph (3), the term `necessary' means the minimum required 
        information that would support a determination by the Secretary 
        that the application provides a reasonable assurance of 
        analytical and clinical validity, or other applicable standard 
        or regulatory requirement, as determined by the Secretary.
            ``(3) Consideration of role of postmarket information.--For 
        purposes of this subsection, the Secretary shall consider the 
        role of postmarket information in determining the least 
        burdensome appropriate means necessary to demonstrate that the 
        applicable standard and other regulatory requirements have been 
        met.
    ``(k) Annual Report.--
            ``(1) In general.--Unless the Secretary specifies 
        otherwise, the holder of an approved application under this 
        section shall submit an annual report each year at a time 
        designated by the Secretary in the approval order. Such report 
        shall--
                    ``(A) identify all modifications required to be 
                reported that an approved application holder has made 
                to any test that is covered by the approval order, 
                including any modification that requires a supplement 
                under subsection (h)(2); and
                    ``(B) include any other information required by the 
                Secretary.
            ``(2) Exception.--The annual reporting requirement in 
        paragraph (1) shall not apply to in vitro clinical tests that 
        are deemed to have a premarket approval based on a prior 
        approval under section 515(c), clearance under section 510(k), 
        or authorization under section 513(f) of this Act, or that are 
        grandfathered under 587A(c).
    ``(l) Service of Orders.--Orders of the Secretary under this 
section with respect to applications under subsection (c) or (d) or 
supplements under subsection (h) shall be served--
            ``(1) in person by any officer or employee of the 
        Department of Health and Human Services designated by the 
        Secretary; or
            ``(2) by mailing the order by registered mail or certified 
        mail or electronic equivalent addressed to the applicant at the 
        last known address in the records of the Secretary.

``SEC. 587C. BREAKTHROUGH IN VITRO CLINICAL TESTS.

    ``(a) In General.--The purpose of this section is to encourage the 
Secretary to apply efficient and flexible approaches to expedite the 
development of, and prioritize the review of, in vitro clinical tests 
that represent breakthrough technologies, and to provide the Secretary 
with sufficient authority to do so.
    ``(b) Establishment of Program.--The Secretary shall establish a 
program to expedite the development of, and provide for the priority 
review of, in vitro clinical tests.
    ``(c) Eligibility.--The program developed under subsection (b) 
shall be available for any in vitro clinical test that--
            ``(1) provides or enables more effective treatment or 
        diagnosis of life-threatening or irreversibly debilitating 
        human disease or conditions compared to existing approved or 
        precertified alternatives; and
            ``(2) is a test--
                    ``(A) that represents a breakthrough technology;
                    ``(B) for which no approved or precertified 
                alternative exists;
                    ``(C) that offers a clinically meaningful advantage 
                over existing approved or precertified alternatives, 
                including the potential, compared to existing approved 
                or precertified alternatives, to reduce or eliminate 
                the need for hospitalization, improve patient quality 
                of life, facilitate patients' ability to manage their 
                own care (such as through self-directed personal 
                assistance), or establish long-term clinical 
                efficiencies; or
                    ``(D) the availability of which is in the best 
                interest of patients or public health.
    ``(d) Designation.--
            ``(1) Request.--To receive breakthrough approval under this 
        section, an applicant may request that the Secretary designate 
        the in vitro clinical test for expedited development and 
        priority review. Any such request for designation may be made 
        at any time prior to the submission of an application under 
        section 587B, and shall include information demonstrating that 
        the test is eligible for designation under subsection (c).
            ``(2) Determination.--Not later than 60 calendar days after 
        the receipt of a request under paragraph (1), the Secretary 
        shall determine whether the in vitro clinical test that is the 
        subject of the request meets the criteria described in 
        subsection (c). If the Secretary determines that the test meets 
        the criteria, the Secretary shall designate the test for 
        expedited development and priority review.
            ``(3) Review.--Review of a request under paragraph (1) 
        shall be undertaken by a team that is composed of experienced 
        staff and senior managers of the Food and Drug Administration.
            ``(4) Withdrawal.--
                    ``(A) In general.--The designation of an in vitro 
                clinical test under this subsection is deemed to be 
                withdrawn, and such in vitro clinical test shall no 
                longer be eligible for designation under this section, 
                if an application for approval under section 587B is 
                denied. Such test shall be eligible for designation 
                upon a new request for such designation.
                    ``(B) Exception.--The Secretary may not withdraw a 
                designation granted under this subsection based on the 
                subsequent approval or technology certification of 
                another test that--
                            ``(i) is designated under this section; or
                            ``(ii) was given priority review under 
                        section 515B.
    ``(e) Actions.--For purposes of expediting the development and 
review of in vitro clinical tests under this section, the Secretary may 
take the actions and additional actions set forth in paragraphs (1) and 
(2), respectively, of section 515B(e) when reviewing such tests. Any 
reference or authorization in section 515B(e) with respect to a device 
shall be deemed a reference or authorization with respect to an in 
vitro clinical test for purposes of this section.
    ``(f) Guidance.--
            ``(1) In general.--Not later than one year after the date 
        of enactment of the Verifying Accurate Leading-edge IVCT 
        Development Act of 2021, the Secretary shall issue draft 
        guidance on the implementation of this section. Such guidance 
        shall--
                    ``(A) set forth the process by which a person may 
                seek a designation under subsection (d);
                    ``(B) provide a template for request under 
                subsection (d);
                    ``(C) identify the criteria the Secretary will use 
                in evaluating a request for designation; and
                    ``(D) identify the criteria and processes the 
                Secretary will use to assign a team of staff, including 
                team leaders, to review in vitro clinical tests 
                designated for expedited development and priority 
                review, including any training required for such 
                personnel to ensure effective and efficient review.
            ``(2) Process.--Prior to finalizing the guidance under 
        paragraph (1), the Secretary shall seek public comment on the 
        draft guidance. The Secretary shall issue final guidance one 
        year after the close of the comment period for the draft 
        guidance.
    ``(g) Annual Report.--Unless otherwise specified by the Secretary, 
the requirements under section 587B(k) apply to in vitro clinical tests 
designated under this section.
    ``(h) Service of Orders.--Orders of the Secretary under this 
section shall be served--
            ``(1) in person by any officer or employee of the 
        Department of Health and Human Services designated by the 
        Secretary; or
            ``(2) by mailing the order by registered mail or certified 
        mail or electronic equivalent addressed to the applicant at his 
        last known address in the records of the Secretary.

``SEC. 587D. TECHNOLOGY CERTIFICATION.

    ``(a) In General.--
            ``(1) Eligibility.--Any eligible person may seek a 
        technology certification order in accordance with this section.
            ``(2) Exception.--An in vitro clinical test is exempt from 
        premarket review under section 587B and may be introduced into 
        interstate commerce if the developer is eligible under this 
        section and the in vitro clinical test--
                    ``(A) is an eligible in vitro clinical test under 
                subsection (b)(2); and
                    ``(B) falls within the scope of a technology 
                certification order issued under this section that is 
                in effect.
    ``(b) Eligibility.--
            ``(1) Eligible person.--In this section, the term `eligible 
        person' means an in vitro clinical test developer unless, at 
        the time such person seeks or would seek technology 
        certification order, the person--
                    ``(A) has been found to have committed a 
                significant violation of section 353 of the Public 
                Health Service Act, unless--
                            ``(i) such violation occurred more than 5 
                        years prior to the date on which such 
                        technology certification order is or would be 
                        sought; or
                            ``(ii) such violation has been resolved;
                    ``(B) fails to maintain required certifications 
                under section 353 of the Public Health Service Act, as 
                applicable; or
                    ``(C) has been found to have submitted information 
                to the Secretary that--
                            ``(i) makes false or misleading statements 
                        about a technology certification order 
                        previously issued or an application approved 
                        under section 587B; or
                            ``(ii) violates any requirement of this 
                        subchapter, where such violation exposes 
                        individuals to serious risk of illness, injury, 
                        or death.
            ``(2) Technology certification eligibility limitations.--An 
        in vitro clinical test is not eligible under subsection (a)(2) 
        for exemption from premarket review under section 587B, if--
                    ``(A) such test is--
                            ``(i) a component or part of an in vitro 
                        clinical test as described in section 
                        201(ss)(1)(B)(v);
                            ``(ii) an instrument under section 
                        201(ss)(1)(B)(ii);
                            ``(iii) a specimen receptacle under section 
                        201(ss)(1)(B)(iii);
                            ``(iv) an in vitro clinical test, including 
                        reagents used in such tests, intended for use 
                        for testing donors, donations, and recipients 
                        of blood, blood components, human cells, 
                        tissues, cellular-based products, or tissue-
                        based products; or
                            ``(v) a high-risk in vitro clinical test 
                        without mitigating measures under section 587E, 
                        which may include first-of-a-kind in vitro 
                        clinical tests, home use in vitro clinical 
                        tests, cross-referenced in vitro clinical 
                        tests, and direct-to-consumer in vitro clinical 
                        tests.
    ``(c) Public Meeting and Input.--
            ``(1) Public docket.--Not later than 30 days after the date 
        of enactment of the Verifying Accurate Leading-edge IVCT 
        Development Act of 2021, the Secretary shall establish a public 
        docket to receive comments concerning recommendations for 
        implementation of this section, including criteria and 
        procedures for subsections (e) through (j). The public docket 
        shall remain open for the duration of time that this section 
        remains in effect.
            ``(2) Public meeting.--Not later than 180 days after the 
        date of enactment of the Verifying Accurate Leading-edge IVCT 
        Development Act of 2021, the Secretary shall convene a public 
        meeting to which stakeholders from organizations representing 
        patients and consumers, academia, and the in vitro clinical 
        test industry are invited in order to discuss the technology 
        certification process including application requirements, 
        inspections, alignment with third-party accreditors, and the 
        definition of `technology' under section 587(17).
    ``(d) Regulations.--The Secretary shall issue regulations on 
technology certification including describing criteria or procedures 
relating to technology certification under this section, which shall be 
subject to public comment for a minimum of 60 days from issuance prior 
to finalizing such regulations after considering the comments received. 
The regulation shall include an outline of the application and 
recertification process, opportunities to meet with officials of the 
Food and Drug Administration and plans to streamline inspections.
    ``(e) Application for Technology Certification.--
            ``(1) In general.--A person seeking a technology 
        certification order shall submit an application under this 
        subsection, which shall contain the information specified under 
        paragraph (2).
            ``(2) Content of application.--An application for 
        technology certification shall contain--
                    ``(A) a statement identifying the scope of the 
                proposed technology certification, which shall be no 
                broader than a single technology intended to be offered 
                under the application;
                    ``(B) information describing that the person 
                seeking a technology certification order is an eligible 
                person under subsection (b)(1);
                    ``(C) information describing that the methods used 
                in, and the facilities and controls used for, the 
                development of eligible in vitro clinical tests covered 
                by the scope of the technology certification conform to 
                the applicable quality requirements of section 587J;
                    ``(D) procedures for analytical validation, 
                including all procedures for validation, verification, 
                and acceptance criteria, and an explanation as to how 
                such procedures, when used, provide a reasonable 
                assurance of analytical validity of eligible in vitro 
                clinical tests within the proposed scope of the 
                technology certification order;
                    ``(E) procedures for clinical validation, including 
                all procedures for validation, verification, and 
                acceptance criteria, and an explanation as to how such 
                procedures, when used, provide a reasonable assurance 
                of clinical validity of eligible in vitro clinical 
                tests within the proposed scope of the technology 
                certification order;
                    ``(F) a submission under section 587I(b) for each 
                in vitro clinical test that the developer intends to 
                introduce into interstate commerce upon receiving a 
                technology certification order;
                    ``(G) information concerning one or more 
                representative in vitro clinical tests, including--
                            ``(i) a test within the scope of the 
                        technology certification application with the 
                        appropriate analytical complexity at the time 
                        of the filing of the application under this 
                        section to serve as the representative test and 
                        validate and run within the developer's stated 
                        scope;
                            ``(ii) the information specified in 
                        subsection (c) or (d) of section 587B, as 
                        applicable, for the representative in vitro 
                        clinical test or tests, including information 
                        and data required pursuant to subsection 
                        (c)(2)(H) of section 587B, unless the Secretary 
                        determines that such information is not 
                        necessary;
                            ``(iii) an explanation of the choice of the 
                        representative in vitro clinical test or tests 
                        for the technology certification application 
                        and how such test adequately demonstrates the 
                        range of procedures that the developer includes 
                        in the application under subparagraphs (C), 
                        (D), (E), and (F); and
                            ``(iv) a brief explanation of the ways in 
                        which the procedures included in the 
                        application under subparagraphs (C), (D), (E), 
                        and (F) have been applied to the representative 
                        in vitro clinical test or tests;
                    ``(H) such other information as the Secretary may 
                determine necessary; and
                    ``(I) a statement that the applicant believes to 
                the best of the applicant's knowledge that all data and 
                information submitted to the Secretary are truthful and 
                accurate and that no material fact has been omitted.
            ``(3) Reference to approved premarket application under 
        section 587b.--With respect to the content requirements in the 
        technology certification application described in paragraph 
        (2), a developer may incorporate by reference any content of an 
        application previously submitted by the developer and approved 
        under section 587B.
    ``(f) Action on an Application for Technology Certification.--
            ``(1) Secretary response.--
                    ``(A) In general.--As promptly as practicable, and 
                no later than 90 days after receipt of an application 
                under subsection (c), the Secretary shall--
                            ``(i) issue a technology certification 
                        order granting the application, which shall 
                        specify the scope of the technology 
                        certification, if the Secretary finds that all 
                        of the grounds in paragraph (3) are met; or
                            ``(ii) deny the application if the 
                        Secretary finds (and sets forth the basis of 
                        such finding as part of or accompanying such 
                        denial) that one or more grounds for granting 
                        the application specified in paragraph (3) are 
                        not met.
                    ``(B) Extension.--The timeline described in 
                subparagraph (A) may be extended by mutual agreement 
                between the Secretary and the applicant.
            ``(2) Deficient applications.--
                    ``(A) If, after receipt of an application under 
                this section, the Secretary determines that any portion 
                of such application is deficient, the Secretary, not 
                later than 60 days after receipt of such application, 
                shall provide to the applicant a description of such 
                deficiencies and identify the information required to 
                correct such deficiencies.
                    ``(B) When responding to the deficiency letter, the 
                applicant may convert the application for technology 
                certification under subsection (c) into a premarket 
                application under section 587B.
            ``(3) Technology certification order.--The Secretary shall 
        grant a technology certification order under this section if, 
        on the basis of the information submitted to the Secretary as 
        part of the application and any other information with respect 
        to such applicant, the Secretary finds that--
                    ``(A) in accordance with subsection (e)(2)(D), 
                there is a showing of reasonable assurance of 
                analytical validity for all eligible in vitro clinical 
                tests within the proposed scope of the technology 
                certification, as evidenced by the procedures for 
                analytical validation;
                    ``(B) in accordance with subsection (e)(2)(E), 
                there is a showing of reasonable assurance of clinical 
                validity for eligible in vitro clinical tests within 
                the proposed scope of the technology certification, as 
                evidenced by the clinical program, including procedures 
                for clinical validation;
                    ``(C) the methods used in, or the facilities or 
                controls used for, the development of eligible in vitro 
                clinical tests covered by the proposed scope of the 
                technology certification conform to the applicable 
                requirements of section 587J;
                    ``(D) based on a fair evaluation of all material 
                facts, the applicant's proposed labeling and 
                advertising is not false or misleading in any 
                particular;
                    ``(E) the application does not contain a false 
                statement of material fact;
                    ``(F) there is a showing that the representative in 
                vitro clinical test or tests--
                            ``(i) meet the applicable standard for such 
                        order; and
                            ``(ii) reasonably represent the range of 
                        procedures for analytical validation and 
                        clinical validation included in the 
                        application, as applicable; and
                    ``(G) the applicant permits authorized employees of 
                the Food and Drug Administration or persons accredited 
                under this Act an opportunity to inspect at a 
                reasonable time and in a reasonable manner the 
                facilities and all pertinent equipment, finished and 
                unfinished materials, containers, and labeling therein, 
                including all things (including records, files, papers, 
                and controls) bearing on whether an in vitro clinical 
                test is adulterated, misbranded, or otherwise in 
                violation of this Act, and permits such authorized 
                employees or persons accredited under this Act to view 
                and to copy and verify all records pertinent to the 
                application and the in vitro clinical test.
            ``(4) Effect of technology certification order.--An in 
        vitro clinical test or tests within the scope of a granted 
        technology certification order are cleared to be introduced 
        into interstate commerce.
            ``(5) Review of denials.--If the Secretary denies an 
        application for technology certification, including an 
        application for renewal under subsection (g), the Secretary 
        will provide a summary of deficiencies on which the Secretary 
        based its denial. An applicant whose application has been 
        denied may, by petition filed on or before the date that is 30 
        calendar days after the date upon which such applicant receives 
        notice of such denial, obtain review thereof in accordance with 
        section 587O.
    ``(g) Duration; Subsequent Submissions.--
            ``(1) Order duration.--A technology certification order 
        shall remain in effect until the earlier of--
                    ``(A) the expiration of such technology 
                certification order under paragraph (2); or
                    ``(B) the withdrawal of such technology 
                certification order under subsection (j).
            ``(2) Expiration.--
                    ``(A) An initial technology certification order 
                issued under subsection (f)(3) shall expire 4 years 
                after the date that such order is issued, except that 
                if an application for renewal under paragraph (3) has 
                been received not later than 30 days prior to the 
                expiration of such order under this paragraph, such 
                order shall expire on the date on which the Secretary 
                has granted or denied the application for renewal. Any 
                such subsequent renewal of a technology certification 
                shall expire on such date specified by the Secretary 
                that is not later than 4 years after the date that such 
                technology certification order is issued.
                    ``(B) In the event of expiration of technology 
                certification order, the clearance of tests introduced 
                into interstate commerce under such order prior to its 
                expiration pursuant to subsection (f)(3) remain in 
                effect.
            ``(3) Renewal.--
                    ``(A) In general.--Any person previously granted a 
                technology certification order in effect may seek 
                renewal of such order provided that--
                            ``(i) such person is an eligible person 
                        under subsection (b)(1);
                            ``(ii) the previously granted technology 
                        certification order--
                                    ``(I) is not on temporary hold 
                                under subsection (i); and
                                    ``(II) was not withdrawn under 
                                subsection (j); and
                            ``(iii) none of the information specified 
                        in subsection (e)(2) has substantially changed, 
                        except as described in supplements to orders 
                        granted under paragraph (4).
                    ``(B) Content.--An application for renewal under 
                this paragraph shall include information concerning one 
                or more representative in vitro clinical tests in 
                accordance with subsection (e)(2)(G), except that such 
                representative test or tests shall be different from 
                the representative test or tests relied upon as the 
                representative assay in any prior technology 
                certification, if applicable.
                    ``(C) Process.--The Secretary's action on an 
                application for renewal of technology certification 
                under this paragraph shall be conducted, to the extent 
                practicable, in coordination with inspections conducted 
                under section 353 of the Public Health Service Act, if 
                applicable, and any order resulting from such renewal 
                application shall be treated as a technology 
                certification order for purposes of this subchapter.
            ``(4) Supplements and reports.--
                    ``(A) Supplements.--Except as provided in 
                subparagraph (B), any person with a technology 
                certification order in effect may seek a supplement to 
                such order upon a change or changes to the information 
                provided in the application for technology 
                certification under subparagraphs (C), (D), and (E) of 
                subsection (e)(2), provided that--
                            ``(i) such person is an eligible person 
                        under subsection (b)(1); and
                            ``(ii) such change does not expand the 
                        scope of the technology certification, unless 
                        the Secretary determines that such expansion is 
                        appropriate.
                A supplement to an order may contain only information 
                relevant to the change or changes. The Secretary's 
                action on a supplement shall be in accordance with 
                subsection (f), and any order resulting from such 
                supplement shall be treated as an amendment to a 
                technology certification order that is in effect.
                    ``(B) Reports.--
                            ``(i) In general.--If a change is made to 
                        an in vitro clinical test or tests that is 
                        beyond the scope of a technology certification 
                        order but is made in order to address a 
                        potential risk to public health by adding a new 
                        specification or test method, the person may 
                        immediately implement such change or changes 
                        and shall report such changes or changes to the 
                        Secretary within 30 days.
                            ``(ii) Content.--Any report to the 
                        Secretary under this subparagraph shall 
                        include--
                                    ``(I) a summary of the relevant 
                                change or changes;
                                    ``(II) the rationale for 
                                implementing such change or changes;
                                    ``(III) a description of how the 
                                change or changes were evaluated; and
                                    ``(IV) data indicating analytical 
                                and clinical validity.
                            ``(iii) Supplemental reports.--Upon review 
                        of such report and a finding that the relevant 
                        change or changes are inconsistent with the 
                        standard specified under this subparagraph, the 
                        Secretary may require a supplement under 
                        subparagraph (A).
    ``(h) Maintenance Requirements.--For the duration of a technology 
certification order, a holder of a technology certification order 
shall--
            ``(1) use the procedures included in the relevant 
        application, supplement, or report under subsections (b) and 
        (e);
            ``(2) ensure compliance with any applicable mitigating 
        measures;
            ``(3) maintain, and provide to the Secretary upon request, 
        records related to any in vitro clinical test offered under the 
        technology certification order, where those records are 
        necessary to demonstrate compliance with applicable provisions 
        of this subchapter; and
            ``(4) comply with the listing requirements under section 
        587I for each in vitro clinical test offered under the 
        technology certification order.
    ``(i) Temporary Hold.--
            ``(1) In general.--Upon one or more findings under 
        paragraph (4) and after promptly notifying the developer of 
        such findings, the Secretary may issue a temporary hold 
        prohibiting any holder of a technology certification order from 
        introducing into interstate commerce an in vitro clinical test 
        that was not previously the subject of a notification under 
        section 587I. The temporary hold must identify the grounds for 
        the temporary hold under paragraph (4) and the rationale for 
        such finding, and may only remain in place until the Secretary 
        responds to a written request under paragraph (3).
            ``(2) Notification to the developer.--The Secretary shall 
        not place a temporary hold under this subsection unless the 
        Secretary has promptly notified the developer of such hold and 
        provided 30 calendar days for the developer to come into 
        compliance with or resolve the findings under paragraph (4).
            ``(3) Written requests.--Any written request to the 
        Secretary from the holder of a technology certification order 
        that a temporary hold under paragraph (1) be removed shall 
        receive a decision, in writing and specifying the reasons 
        therefore, within 90 days after receipt of such request. Any 
        such request shall include information to support the removal 
        of the temporary hold.
            ``(4) Grounds for temporary hold.--A temporary hold under 
        this subsection may be instated upon a finding or findings that 
        the holder of a technology certification order--
                    ``(A) is not in compliance with any maintenance 
                requirements under subsection (h);
                    ``(B) labels or advertises one or more in vitro 
                clinical tests with false or misleading claims; or
                    ``(C) is no longer an eligible person under 
                subsection (b)(1).
    ``(j) Withdrawal.--The Secretary may, after due notice and 
opportunity for informal hearing, issue an order withdrawing a 
technology certification order if the Secretary finds that--
            ``(1) the application, supplement, or report under 
        subsection (e) or (g) contains materially false or misleading 
        information or fails to reveal a material fact;
            ``(2) such holder fails to correct materially false or 
        misleading labeling or advertising upon the request of the 
        Secretary;
            ``(3) in connection with a technology certification, the 
        holder provides materially false or misleading information to 
        the Secretary; or
            ``(4) the holder of such technology certification order 
        fails to correct the grounds for temporary hold within a 
        timeframe specified in the temporary hold order.
    ``(k) Reports to Congress.--
            ``(1) In general.--Not later than one year after date of 
        enactment of the Verifying Accurate Leading-edge IVCT 
        Development Act of 2021, and annually thereafter for the next 4 
        years, the Secretary shall submit to the Committee on Energy 
        and Commerce of the House of Representatives and the Committee 
        on Health, Education, Labor, and Pensions of the Senate, and 
        make publicly available, including through posting on the 
        website of the Food and Drug Administration, a report 
        containing the information described in paragraph (2).
            ``(2) Content.--
                    ``(A) In general.--Each report under paragraph (1) 
                shall address, at a minimum--
                            ``(i) the total number of applications for 
                        technology certifications filed, granted, 
                        withdrawn and denied;
                            ``(ii) the total number of technology 
                        certification orders put on temporary hold 
                        under subsection (i) and the number of 
                        technology certification orders withdrawn under 
                        subsection (j);
                            ``(iii) the types of technologies for which 
                        technology certification orders were granted;
                            ``(iv) the total number of developers, 
                        including laboratories, with technology 
                        certification orders in effect; and
                            ``(v) the total number of approved tests 
                        under section 587B that were reclassified and 
                        granted a technology certification order under 
                        this section.
                    ``(B) Final report.--The fifth report submitted 
                under paragraph (1) shall include a summary of, and 
                responses to, comments raised in the meeting and 
                docket.
                    ``(C) Performance reports.--The reports required 
                under this section may be issued with performance 
                reports as required under section 9 of the Verifying 
                Accurate Leading-edge IVCT Development Act of 2021.

``SEC. 587E. MITIGATING MEASURES.

    ``(a) Establishment of Mitigating Measures.--
            ``(1) Establishing, changing, or withdrawing.--
                    ``(A) Establishment.--If the Secretary requires the 
                establishment of mitigating measures pursuant to clause 
                (i) or (ii) of section 587(15)(A) for any in vitro 
                clinical test, the Secretary may require such 
                mitigating measures for any other in vitro clinical 
                test with the same indications for use.
                    ``(B) Process.--Notwithstanding subchapter II of 
                chapter 5 of title 5, United States Code, the Secretary 
                may--
                            ``(i) establish, change, or withdraw 
                        mitigating measures by--
                                    ``(I) publishing a proposed 
                                administrative order in the Federal 
                                Register;
                                    ``(II) providing an opportunity for 
                                public comment for a period of not less 
                                than 30 calendar days; and
                                    ``(III) after consideration of any 
                                comments submitted, publishing a final 
                                administrative order in the Federal 
                                Register; and
                            ``(ii) may establish mitigating measures 
                        with respect to a category in a premarket 
                        approval order or technology certification 
                        order.
            ``(2) In vitro clinical tests previously approved, cleared, 
        or exempted as devices.--
                    ``(A) In general.--Any special controls or 
                restrictions applicable to an in vitro clinical test 
                with the same indications for use pursuant to section 
                587(10) based on prior regulation as a device approved 
                under section 515, cleared or exempt under section 
                510(k), or classified under section 513(f)(2), 
                including any such special controls or restrictions 
                established during the period beginning on the date of 
                enactment of the Verifying Accurate Leading-edge IVCT 
                Development Act of 2021 and ending on the effective 
                date of such Act (as described in section 5(b) of such 
                Act)--
                            ``(i) shall continue to apply to such 
                        approved, cleared, or exempted in vitro 
                        clinical test after such effective date; and
                            ``(ii) are deemed to be mitigating measures 
                        as of the effective date of such approval, 
                        clearance, or exemption.
                    ``(B) Changes.--The Secretary may establish, 
                change, or withdraw mitigating measures for such a test 
                or indications for use the procedures under paragraph 
                (1).
    ``(b) Documentation.--
            ``(1) Tests subject to premarket review.--The developer of 
        an in vitro clinical test subject to premarket review under 
        section 587B and to which mitigating measures apply shall--
                    ``(A) in accordance with section 587B(c)(2)(G)(i), 
                submit documentation to the Secretary as part of the 
                application for the test under subsection (c) or (d) of 
                section 587B demonstrating that such mitigating 
                measures have been met;
                    ``(B) if such application is approved, maintain 
                documentation demonstrating that such mitigating 
                measures continue to be met following a test 
                modification by the developer; and
                    ``(C) after responding to any informal 
                communications from the Secretary, make such 
                documentation available to the Secretary upon request 
                or inspection.
            ``(2) Other tests.--The developer of an in vitro clinical 
        test that is marketed within the scope of a technology 
        certification order or other exemption from premarket review 
        under section 587B and to which mitigating measures apply 
        shall--
                    ``(A) maintain documentation in accordance with the 
                applicable quality requirements under section 587J 
                demonstrating that such mitigating measures continue to 
                be met following a test modification by the developer;
                    ``(B) after responding to any informal 
                communications from the Secretary, make such 
                documentation available to the Secretary upon request 
                or inspection; and
                    ``(C) include in the performance summary for such 
                test a brief description of how such mitigating 
                measures are met, if applicable.
    ``(c) Mitigating Measures for Cross-Referenced Tests.--Not later 
than 1 year after the implementation of the Verifying Accurate Leading-
edge IVCT Development Act of 2021, the Secretary shall issue mitigating 
measures for cross-referenced tests.

``SEC. 587F. REGULATORY PATHWAY REDESIGNATION.

    ``(a) Technology Certification and Exemption Determinations.--
            ``(1) In general.--Based on new information, including the 
        establishment of mitigating measures under section 587E, and 
        after considering available evidence respecting tests with the 
        same indications for use pursuant to section 587(10), the 
        Secretary may, upon the initiative of the Secretary or upon 
        petition of an interested person--
                    ``(A) revoke any exemption or requirement in effect 
                under this subchapter with respect to such indications 
                for use; or
                    ``(B) determine that such indications for use are 
                eligible for technology certification in accordance 
                with section 587D(b)(2).
            ``(2) Process.--Any action under paragraph (1) shall be 
        made by publication of a notice of such proposed action on the 
        website of the Food and Drug Administration, the consideration 
        of comments to a public docket on such proposal, and 
        publication of a final action on such website within 60 
        calendar days of the close of the comment period posted to such 
        public docket, notwithstanding subchapter II of chapter 5 of 
        title 5, United States Code.
    ``(b) Revocation.--The Secretary may revoke any exemption with 
respect to such test or indications for use pursuant to section 
587(10), if--
            ``(1) new clinical information indicates that the exemption 
        of an in vitro clinical test or tests from premarket review 
        under section 587B or exemption under section 587A has a 
        reasonable probability of severe adverse health consequences, 
        including the absence, delay, or discontinuation of appropriate 
        medical treatment.
            ``(2) Process.--Any action under this subsection shall be 
        made by publication of a notice of such proposed action in the 
        Federal Register, consideration of comments to a public docket 
        on such proposal, and publication of a final notice in the 
        Federal Register, notwithstanding subchapter II of chapter 5 of 
        title 5, United States Code.

``SEC. 587G. ADVISORY COMMITTEES.

    ``(a) In General.--The Secretary may establish advisory committees 
or use advisory committee panels of experts established before the date 
of enactment of this section for the purposes of providing expert 
scientific advice and making recommendations related to--
            ``(1) the approval of an application for an in vitro 
        clinical test submitted under this subchapter, including for 
        evaluating, as applicable, the analytical validity, clinical 
        validity, and safety of in vitro clinical tests;
            ``(2) the potential effectiveness of mitigating measures 
        for a determination on the applicable regulatory pathway under 
        section 587F or risk evaluation for an in vitro clinical test 
        or tests;
            ``(3) quality requirements under section 587J or applying 
        such requirements to in vitro clinical tests developed or 
        imported by developers; or
            ``(4) such other purposes as the Secretary determines 
        appropriate.
    ``(b) Appointments.--
            ``(1) Voting members.--The Secretary shall appoint to each 
        committee established under subsection (a), as voting members, 
        individuals who are qualified by training and experience to 
        evaluate in vitro clinical tests referred to the committee for 
        the purposes specified in subsection (a), including individuals 
        with, to the extent feasible, scientific expertise in the 
        development, manufacture, or utilization of such in vitro 
        clinical tests, laboratory operations, and the use of in vitro 
        clinical tests. The Secretary shall designate one member of 
        each committee to serve as chair.
            ``(2) Nonvoting members.--In addition to the individuals 
        appointed pursuant to paragraph (1), the Secretary shall 
        appoint to each committee established under subsection (a), as 
        nonvoting members--
                    ``(A) a representative of consumer interests; and
                    ``(B) a representative of interests of in vitro 
                clinical test developers not directly affected by the 
                matter to be brought before the committee.
            ``(3) Limitation.--No individual who is in the regular 
        full-time employee of the United States and engaged in the 
        administration of this Act may be a member of any advisory 
        committee established under subsection (a).
            ``(4) Education and training.--The Secretary shall, as 
        appropriate, provide education and training to each new 
        committee member before such member participates in a 
        committee's activities, including education regarding 
        requirements under this Act and related regulations of the 
        Secretary, and the administrative processes and procedures 
        related to committee meetings.
            ``(5) Meetings.--The Secretary shall ensure that scientific 
        advisory committees meet regularly and at appropriate intervals 
        so that any matter to be reviewed by such a committee can be 
        presented to the committee not more than 60 calendar days after 
        the matter is ready for such review. Meetings of the committee 
        may be held using electronic communication to convene the 
        meetings.
            ``(6) Compensation.--Members of an advisory committee 
        established under subsection (a), while attending meetings or 
        conferences or otherwise engaged in the business of the 
        advisory committee--
                    ``(A) shall be entitled to receive compensation at 
                rates to be fixed by the Secretary, but not to exceed 
                the daily equivalent of the rate in effect for 
                positions classified above level GS-15 of the General 
                Schedule; and
                    ``(B) may be allowed travel expenses as authorized 
                by section 5703 of title 5, United States Code, for 
                employees serving intermittently in the Government 
                service.
    ``(c) Guidance.--The Secretary may issue guidance on the policies 
and procedures governing advisory committees established under 
subsection (a).

``SEC. 587H. REQUEST FOR INFORMAL FEEDBACK.

    ``Before submitting a premarket application or technology 
certification application for an in vitro clinical test--
            ``(1) the developer of the test may submit to the Secretary 
        a written request for a meeting, conference, or written 
        feedback to discuss and provide information relating to the 
        regulation of such in vitro clinical test which may include--
                    ``(A) the submission process and the type and 
                amount of evidence expected to demonstrate the 
                applicable standard;
                    ``(B) which regulatory pathway is appropriate for 
                an in vitro clinical test; and
                    ``(C) an investigation plan for an in vitro 
                clinical test, including a clinical protocol; and
            ``(2) upon receipt of such a request, the Secretary shall--
                    ``(A) within 60 calendar days after such receipt, 
                or within such time period as may be agreed to by the 
                developer, meet or confer with the developer submitting 
                the request; and
                    ``(B) within 15 calendar days after such meeting or 
                conference, provide to the developer a written record 
                or response describing the issues discussed and 
                conclusions reached in the meeting or conference.

``SEC. 587I. REGISTRATION AND LISTING.

    ``(a) Registration of Establishments for In Vitro Clinical Tests.--
            ``(1) In general.--Each person described in subsection 
        (b)(1), or an accredited person under section 587P, acting on 
        behalf of such a person, shall--
                    ``(A) during the period beginning on October 1 and 
                ending on December 31 of each year, register with the 
                Secretary the name of such person, places of business 
                of such person, all establishments engaged in the 
                activities specified under this paragraph, the 
                establishment registration number of each such 
                establishment, and a point of contact for each such 
                establishment, including an electronic point of 
                contact; and
                    ``(B) submit an initial registration containing the 
                information required under subparagraph (A) not later 
                than--
                            ``(i) the date of implementation of this 
                        section if such establishment is engaged in any 
                        activity described in subsection (b)(1) on the 
                        date of enactment of this section, unless the 
                        Secretary establishes by guidance a date later 
                        than such implementation date for all or a 
                        category of such establishments; or
                            ``(ii) 30 days prior to engaging in any 
                        activity described in subsection (b)(1) after 
                        enactment of this section, if such 
                        establishment is not engaged in any activity 
                        described in this paragraph on the date of 
                        enactment of this section.
            ``(2) Registration numbers.--The Secretary may assign a 
        registration number to any person or an establishment 
        registration number to any establishment registered in 
        accordance with this section. Registration information shall be 
        made publicly available by publication on the website 
        maintained by the Food and Drug Administration, in accordance 
        with subsection (d).
            ``(3) Inspection.--Each person or establishment that is 
        required to be registered with the Secretary under this section 
        shall be subject to inspection pursuant to section 704.
    ``(b) Listing Information for In Vitro Clinical Tests.--
            ``(1) In general.--Each person who--
                    ``(A) is a developer, a contract manufacturer 
                (including contract packaging), contract sterilizer, 
                repackager, relabeler, or distributor of an in vitro 
                clinical test; and
                    ``(B) introduces or proposes to begin the 
                introduction or delivery for introduction into 
                interstate commerce through an exemption under section 
                587A(f)(2)(b) or 587A(g) or through the filing of an 
                application under section 587B or 587D,
        shall submit a listing to the Secretary containing the 
        information described in paragraph (2) in accordance with the 
        applicable schedule described under subsection (c). Such 
        listing shall be prepared in such form and manner as the 
        Secretary may specify in guidance. Listing information shall be 
        submitted through the comprehensive test information system in 
        accordance with section 587T, as appropriate.
            ``(2) Submissions.--Each developer submitting a listing 
        under paragraph (1) shall electronically submit to the 
        comprehensive test information system under section 587T the 
        following information for each in vitro clinical test for which 
        such person is a developer in the form and manner prescribed by 
        the Secretary:
                    ``(A) Name of the establishment and its 
                establishment registration number.
                    ``(B) Contact information for the official 
                correspondent for the listing.
                    ``(C) Name (common name and trade name, if 
                applicable) of the in vitro clinical test and its test 
                listing number (when available).
                    ``(D) CLIA certificate number for any laboratory 
                certified by the Secretary under section 353 of the 
                Public Health Service Act that meets the requirements 
                for performing high-complexity testing that is the 
                developer of the in vitro clinical test, and CLIA 
                certificate number for any laboratory under common 
                ownership that is performing the test developed by such 
                test developer.
                    ``(E) Whether the in vitro clinical test is, as 
                applicable, offered as a test approved under section 
                587B, offered under a technology certification o, or 
                offered as an in vitro clinical test under section 
                587Arder issued under section 587D.
                    ``(F) Indications for use information under section 
                587(10).
                    ``(G) Brief narrative description of the in vitro 
                clinical test.
                    ``(H) A brief summary of the analytical and 
                clinical performance of the in vitro clinical test, and 
                as applicable, the lot release criteria.
                    ``(I) A brief description of conformance with any 
                applicable mitigating measures, restrictions, and 
                standards.
                    ``(J) Representative labeling for the in vitro 
                clinical test, as appropriate.
                    ``(K) A statement that the information submitted is 
                truthful and accurate.
            ``(3) Test listing number.--The Secretary may assign a test 
        listing number to each in vitro clinical test that is the 
        subject of a listing under this section. The process for 
        assigning test listing numbers may be established through 
        guidance, and may include the recognition of standards, 
        formats, or conventions developed by a third-party 
        organization.
            ``(4) Abbreviated listing.--A person who is not a developer 
        but is otherwise required to register pursuant to subsection 
        (a) shall submit an abbreviated listing to the Secretary 
        containing the information described in subparagraphs (A) 
        through (C) of paragraph (2), and the name of the developer. 
        The information shall be submitted in accordance with the 
        applicable schedule described under subsection (c). Such 
        abbreviated listing shall be prepared in such form and manner 
        as the Secretary may specify in guidance. Listing information 
        shall be submitted to the comprehensive test information system 
        in accordance with section 587T, as appropriate.
            ``(5) Grandfathered tests.--A developer of an in vitro 
        clinical test developer offering a test that is grandfathered 
        under section 587A(c) shall submit listing information required 
        under subparagraphs (A) through (K) of paragraph (2).
            ``(6) Low-risk tests.--A developer of a low risk in vitro 
        clinical test shall notify and submit listing information to 
        the Secretary within one year of offering such test for 
        clinical use.
            ``(7) Exempt tests.--A developer of an in vitro clinical 
        test who introduces or proposes to begin the introduction or 
        delivery for introduction into interstate commerce pursuant to 
        an exemption under section 587A may submit listing information 
        under this subsection.
    ``(c) Timelines for Submission.--
            ``(1) In general.--The timelines for submission of 
        registration and listing under subsections (a) and (b) are as 
        follows:
                    ``(A) For an in vitro clinical test that was listed 
                as a device under section 510(j) prior to the date of 
                enactment of this section, a person shall maintain a 
                device listing under section 510 until such time as the 
                system for submitting the notification information 
                required under subsection (b) becomes available and 
                thereafter shall submit the notification information no 
                later than 1 year after the system for submitting the 
                notification under this section becomes available.
                    ``(B) For an in vitro clinical test that is subject 
                to the grandfathering provisions of section 587A(c), a 
                person shall submit the listing information required 
                under subsection (b)(5) no later than 1 year after the 
                system for submitting the notification under this 
                section becomes available.
                    ``(C) For an in vitro clinical test that is not 
                described in subparagraph (A) or (B), a person shall 
                submit the required notification information prior to 
                offering, introducing, or marketing the in vitro 
                clinical test as follows:
                            ``(i) For an in vitro clinical test that is 
                        not exempt from premarket approval under 
                        section 587B, a person shall submit the 
                        required listing information no later than 30 
                        business days after the date of approval of the 
                        premarket approval application.
                            ``(ii) For a developer who has received a 
                        technology certification order under section 
                        587D, a person shall submit the required 
                        listing information at least 30 business days 
                        after receiving such technology certification 
                        order.
            ``(2) Updates.--
                    ``(A) Updates after changes.--Each developer 
                required to submit listing information under this 
                section shall update such information within 10 
                business days of any change that causes any previously 
                notified information to be inaccurate or incomplete.
                    ``(B) Annual updates.--Each developer required to 
                submit listing information under this section shall 
                update its information annually during the period 
                beginning on October 1 and ending on December 31 of 
                each year as a component of the annual report submitted 
                under sections 587B and 587D.
    ``(d) Public Availability of Notification Information.--
            ``(1) In general.--Notification information submitted 
        pursuant to this section shall be made publicly available on 
        the website of the Food and Drug Administration in accordance 
        with paragraph (3).
            ``(2) Confidentiality.--Notification information for an in 
        vitro clinical test that is subject to premarket approval or 
        technical certification shall remain confidential until such 
        date as the in vitro clinical test receives the applicable 
        premarket approval or the developer receives a technology 
        certification order.
            ``(3) Exceptions from public availability requirements.--
        The registration and listing information requirements described 
        in subsections (a) and (b) shall not apply to the extent the 
        Secretary determines that such information relates to--
                    ``(A) trade secret or commercial confidential 
                information; or
                    ``(B) national security or countermeasures or is 
                restricted from disclosure pursuant to another 
                provision of law.
    ``(e) Submission of Information by Accredited Persons.--If agreed 
upon by the developer, the information required under this section may 
be submitted by an accredited person under section 587P.

``SEC. 587J. TEST DESIGN AND QUALITY REQUIREMENTS.

    ``(a) Applicability.--
            ``(1) In general.--Each developer and each other person 
        required to register under section 587I(b)(1) shall establish 
        and maintain quality requirements in accordance with the 
        applicable requirements set forth in subsection (b), except as 
        provided in section 587A.
            ``(2) Certified laboratory requirements.--A developer that 
        operates a clinical laboratory certified by the Secretary under 
        section 353 of the Public Health Service Act that--
                    ``(A) meets the requirements for performing high-
                complexity testing;
                    ``(B)(i) develops an vitro clinical test or 
                indications for use; or
                    ``(ii) modifies another developer's in vitro 
                clinical test in that certified laboratory in a manner 
                described in section 587(6)(C); and
                    ``(C) develops an in vitro clinical test or 
                indications for use that are for use only within that 
                certified laboratory or within another certified 
                laboratory with common ownership,
         shall establish and maintain quality requirements that comply 
        with the requirements set forth in subsection (b)(2).
            ``(3) Applicability for certain in vitro clinical tests.--
        The applicable requirements set forth in subsection (b)(1) 
        shall apply to any instrument, specimen receptacle, or 
        component or part that is developed for use by a clinical 
        laboratory to which paragraph (2) applies.
            ``(4) Regulations.--In promulgating regulations under this 
        section, the Secretary shall consider whether and to what 
        extent international harmonization is appropriate.
    ``(b) Quality Requirements.--
            ``(1) Quality requirements for laboratories without clia 
        certification to conduct high-complexity tests.--The quality 
        requirements applicable under this section shall--
                    ``(A) avoid duplication of regulations under 
                section 353 of the Public Health Service Act;
                    ``(B) apply only to the development, validation, 
                production, preparation, propagation, or assembly 
                related to the design and associated manufacture and 
                distribution of an in vitro clinical test offered under 
                this subchapter;
                    ``(C) not apply with respect to laboratory 
                operations; and
                    ``(D) shall include the following, subject to 
                paragraphs (2) and (3)--
                            ``(i) management responsibility;
                            ``(ii) quality audits;
                            ``(iii) personnel;
                            ``(iv) design controls;
                            ``(v) document controls;
                            ``(vi) purchasing controls;
                            ``(vii) identification and traceability;
                            ``(viii) production and process controls;
                            ``(ix) acceptance activities;
                            ``(x) nonconforming product;
                            ``(xi) corrective and preventive action;
                            ``(xii) labeling and packaging controls;
                            ``(xiii) handling, storage, distribution, 
                        and installation;
                            ``(xiv) records;
                            ``(xv) servicing; and
                            ``(xvi) statistical techniques.
            ``(2) Quality requirements for laboratories certified to 
        conduct high-complexity tests.--Quality requirements applicable 
        to the in vitro clinical tests and developers described in 
        subsection (a)(2) shall--
                    ``(A) avoid duplication of regulations under 
                section 353 of the Public Health Service Act; and
                    ``(B) consist of, as directed related to the design 
                and development--
                            ``(i) design controls;
                            ``(ii) purchasing controls;
                            ``(iii) acceptance activities;
                            ``(iv) corrective and preventative action; 
                        and
                            ``(v) records.
            ``(3) Quality requirements for certain laboratories 
        distributing in vitro clinical tests or test protocols within 
        organizations or public health networks.--
                    ``(A) In general.--Quality requirements applicable 
                to the developer who is distributing in vitro clinical 
                test distributed as described in subparagraph (B) shall 
                consist of the following:
                            ``(i) The requirements in paragraph (2).
                            ``(ii) The labeling requirements in 
                        paragraph (1)(C)(xii).
                            ``(iii) The requirement to maintain records 
                        of the laboratories to which the in vitro 
                        clinical test or test protocol is distributed.
                    ``(B) Distributing laboratory.--Subparagraph (A) 
                shall apply to developers that meet the following 
                conditions:
                            ``(i) The laboratory distributing the test 
                        protocol is certified by the Secretary under 
                        section 353 of the Public Health Service Act 
                        and meets the requirements for performing high-
                        complexity testing.
                            ``(ii) The laboratory develops its own in 
                        vitro clinical test or modifies another 
                        developer's in vitro clinical test in a manner 
                        described in section 587(6)(C).
                            ``(iii) The laboratory distributes the in 
                        vitro clinical test or test protocol for such 
                        test only to another laboratory that--
                                    ``(I) is certified by the Secretary 
                                under section 353 of the Public Health 
                                Service Act and meets the requirements 
                                for performing high-complexity testing;
                                    ``(II) is within the same corporate 
                                organization and having common 
                                ownership by the same parent 
                                corporation; or as applicable, is a 
                                laboratory within a public health 
                                laboratory network coordinated or 
                                managed by the Centers for Disease 
                                Control and Prevention; and
                                    ``(III) implements the test 
                                protocol without further modification.
    ``(c) Regulations.--In implementing quality requirements for test 
developers under this section, the Secretary shall--
            ``(1) for purposes of facilitating international 
        harmonization, consider whether the developer participates in 
        an audit program in which the United States participates or the 
        United States recognizes or conforms with standards recognized 
        by the Secretary; and
            ``(2) ensure a least burdensome approach described in 
        section 587B(j) by leveraging, to the extent applicable, the 
        quality assurance requirements applicable to developers 
        certified by the Secretary under section 353 of the Public 
        Health Service Act.

``SEC. 587K. LABELING REQUIREMENTS.

    ``(a) In General.--An in vitro clinical test shall bear or be 
accompanied by labeling, and a label as applicable, that meet the 
requirements set forth in subsections (b) and (c), unless such test is 
exempt as specified in subsection (d) or (e).
    ``(b) Labels.--
            ``(1) In general.--The label of an in vitro clinical test 
        shall meet the requirements set forth in paragraph (2), except 
        this requirement shall not apply to an in vitro clinical test 
        that--
                    ``(A) consists solely of a test protocol; or
                    ``(B) is developed, manufactured, and used solely 
                within a single laboratory certified by the Secretary 
                under section 353 of the Public Health Service Act that 
                meets the requirements for performing high-complexity 
                testing.
            ``(2) Regulations.--The label of an in vitro clinical test 
        shall state the name and place of business of its developer and 
        meet the requirements set forth in regulations promulgated 
        under this section.
    ``(c) Labeling.--
            ``(1) In general.--Labeling accompanying an in vitro 
        clinical test, including labeling in the form of a package 
        insert, standalone laboratory reference document, or other 
        similar document except the labeling specified in paragraph 
        (2), shall include adequate directions for use and shall meet 
        the requirements set forth in regulations promulgated under 
        this section, except as provided in subsection (d) or (e).
            ``(2) Content.--
                    ``(A) In general.--Labeling accompanying an in 
                vitro clinical test that is in the form of a test 
                report template or ordering information shall include--
                            ``(i) the test listing number that was 
                        provided to the developer at the time of 
                        listing;
                            ``(ii) instructions for how and where to 
                        report an adverse event under section 587L;
                            ``(iii) instructions for how and where to 
                        access the performance summary data displayed 
                        in the listing database for the test;
                            ``(iv) the intended use of the in vitro 
                        clinical test; and
                            ``(v) any warnings, contraindications, or 
                        limitations.
                    ``(B) Public availability of information.--The 
                Secretary shall make all of the information described 
                in subparagraph (A) with respect to each in vitro 
                clinical test available to the public, as applicable, 
                in accordance with section 587T, except to the extent 
                that the Secretary determines that such information 
                is--
                            ``(i) trade secret or commercial 
                        confidential information; or
                            ``(ii) national security or countermeasures 
                        or is restricted from disclosure pursuant to 
                        another provision of law.
            ``(3) Additional requirements.--Labeling for an in vitro 
        clinical test used for immunohematology testing shall meet the 
        applicable requirements set forth in part 660 of title 21, Code 
        of Federal Regulations (or any successor regulations), related 
        to the labeling of blood grouping reagents, reagent red blood 
        cells, and anti-human globulin.
    ``(d) Exemptions and Alternative Requirements.--
            ``(1) In general.--
                    ``(A) In general.--With respect to an in vitro 
                clinical test that meets the criteria of subparagraph 
                (B), the `state in one place' regulations under section 
                809.10(b) of title 21 of the Code of Federal 
                Regulations (or any successor regulations) may be 
                satisfied by the laboratory posting such information on 
                its website or in multiple documents, if such documents 
                are maintained and accessible in one place.
                    ``(B) Applicable tests.--An in vitro clinical test 
                meets the criteria of this subparagraph if such test 
                is--
                            ``(i) designed and manufactured by a 
                        laboratory certified by the Secretary under 
                        section 353 of the Public Health Service Act 
                        that meets the requirements for performing 
                        high-complexity testing; and
                            ``(ii) performed in the same laboratory in 
                        which it was developed or by another such 
                        laboratory certified by the Secretary under 
                        section 353 of the Public Health Service Act 
                        that meets the requirements for performing high 
                        complexity testing and is under common 
                        ownership with the laboratory that designed and 
                        manufactured the test.
            ``(2) Test instrument labeling.--The labeling for an 
        instrument is not required to bear the information indicated in 
        paragraphs (3), (4), (5), (7), (8), (9), (10), (11), (12), and 
        (13) of section 809.10(b) of title 21 of the Code of Federal 
        Regulations (or any successor regulations).
            ``(3) Reagent labeling.--For purposes of compliance with 
        subsection (c)(1), the labeling for a reagent intended for use 
        as a replacement in an in vitro clinical test may be limited to 
        that information necessary to identify the reagent adequately 
        and to describe its proper use in the system.
            ``(4) Lab research or investigational use.--A shipment or 
        other delivery of an in vitro clinical test for research or 
        investigational use pursuant to section 587A(m) shall be exempt 
        from the labeling requirements of subsections (b) and (c)(1) 
        and from any standard promulgated through regulations, except 
        as required under section 353 of the Public Health Service Act 
        or section 587R of this Act.
            ``(5) General purpose laboratory reagents.--The labeling of 
        general purpose laboratory reagents (such as hydrochloric acid) 
        whose uses are generally known by persons trained in their use 
        need not bear the directions for use required by subsections 
        (b) and (c)(1).
            ``(6) Analyte specific reagents.--The labeling for analyte 
        specific reagents shall bear the following statement: `This 
        product is intended solely for further development of an in 
        vitro clinical test and is exempt from most FDA regulation. 
        This product must be evaluated by the in vitro clinical test 
        developer in accordance with applicable requirements.'. If the 
        labeling of an analyte specific reagent bears the statement set 
        forth in this paragraph, it need not bear the information 
        required by subsection (c)(1).
            ``(7) Over-the-counter test sample collection systems 
        labeling.--The labeling for over-the-counter test sample 
        collection systems for drugs of abuse testing shall bear the 
        name and place of business of the developer included in the 
        registration listing under section 587I, in language 
        appropriate for the intended users.
    ``(e) Tests in the Strategic National Stockpile.--
            ``(1) In general.--The Secretary may grant an exception or 
        alternative to any provision listed in this section, unless 
        explicitly required by a statutory provision outside this 
        subchapter, for specified lots, batches, or other units of an 
        in vitro clinical test, if the Secretary determines that 
        compliance with such labeling requirement could adversely 
        affect the safety, effectiveness, or availability of such 
        products that are or will be included in the Strategic National 
        Stockpile under section 319F-2 of the Public Health Service 
        Act.
            ``(2) Regulations.--The Secretary may issue regulations 
        amending section 809.11 of title 21 of the Code of Federal 
        Regulations or any successor regulation to apply in full or in 
        part to in vitro clinical tests and in vitro clinical test 
        developers.
    ``(f) Guidance.--The Secretary may, in collaboration with 
developers, issue guidance on standardized, general content and format 
for in vitro clinical test labeling to help ensure compliance with 
applicable requirements in this subsection.

``SEC. 587L. ADVERSE EVENT REPORTING.

    ``(a) Applicability.--
            ``(1) In general.--Each in vitro clinical test developer 
        shall establish and maintain a system for reporting adverse 
        events in accordance with subsection (b), except as provided in 
        section 587A.
            ``(2) Regulations.--The Secretary shall promulgate 
        regulations to implement this section, including information 
        necessary to be reported to ensure the analytical and clinical 
        validity of in vitro clinical tests, and the safety of articles 
        for taking or deriving specimens from the human body.
    ``(b) Adverse Event Reporting Requirements.--Each developer shall 
report to the Secretary whenever information that reasonably suggests 
that one of the developer's in vitro clinical tests is associated with 
an adverse event becomes known to the developer.
    ``(c) Reports.--Reports required under this section shall be 
submitted as follows:
            ``(1) An individual adverse event report shall be submitted 
        for the following events not later than--
                    ``(A) 5 calendar days after an in vitro clinical 
                test developer receives or otherwise becomes aware of 
                information that reasonably suggests the adverse event 
                involves a patient death; or
                    ``(B) 5 calendar days after an in vitro clinical 
                test developer receives or otherwise becomes aware of 
                information that reasonably suggests the event presents 
                an imminent threat to public health.
            ``(2) Quarterly reports shall be submitted for all other 
        adverse events, if any, and no later than the end of the 
        quarter following the quarter in which the adverse event 
        information was received by the in vitro clinical test 
        developer.
    ``(d) Definitions.--In this section--
            ``(1) the term `adverse event'--
                    ``(A) means--
                            ``(i) death of, or serious injury to, a 
                        specific patient or user for which it is 
                        reasonably believed that an in vitro clinical 
                        test error contributed to such death or serious 
                        injury; or
                            ``(ii) an in vitro clinical test error that 
                        may have reasonable likelihood to cause serious 
                        injury or death; and
                    ``(B) excludes laboratory errors that are subject 
                to the requirements of section 353 of the Public Health 
                Service Act and corrective or preventive actions to 
                prevent such errors;
            ``(2) the term `in vitro clinical test error'--
                    ``(A) means a failure in an in vitro clinical test 
                to meet the analytical or clinical validity standard or 
                otherwise perform as intended by the developer; and
                    ``(B) includes an inaccurate false result that 
                reaches a health care provider, patient, or consumer, 
                except that such term excludes any such event or error 
                related to laboratory operations pursuant to section 
                353 of the Public Health Service Act; and
            ``(3) the term `serious injury' means--
                    ``(A) a significant delay in a critical diagnosis 
                or causing the absence, delay, or discontinuation of 
                critical medical treatment or that irreversibly or 
                seriously and negatively alters the course of the 
                disease or condition; or
                    ``(B) an injury that--
                            ``(i) is life threatening;
                            ``(ii) results in permanent impairment of a 
                        body function or permanent damage to a body 
                        structure; or
                            ``(iii) necessitates medical or surgical 
                        intervention to preclude permanent impairment 
                        of a body function or permanent damage to a 
                        body structure.

``SEC. 587M. CORRECTIONS AND REMOVALS.

    ``(a) In General.--The Secretary shall promulgate regulations to 
implement this section, including information necessary to be reported 
to ensure the analytical and clinical validity of in vitro clinical 
tests, and the safety of specimen receptacles.
    ``(b) Reports of Removals and Corrections.--
            ``(1) In general.--Each in vitro clinical test developer or 
        importer shall report to the Secretary any correction or 
        removal of an in vitro clinical test undertaken by such 
        developer or importer if the removal or correction was 
        undertaken--
                    ``(A) to reduce the risk to health posed by the in 
                vitro clinical test; or
                    ``(B) to remedy a violation of this Act caused by 
                the in vitro clinical test which may present a risk to 
                health.
            ``(2) Exception.--No report of the correction or removal of 
        an in vitro clinical test is required under paragraph (1) if a 
        report of the correction or removal is required under, and has 
        been submitted under, section 587L.
    ``(c) Timing.--A developer or importer shall submit any report 
required under this subsection to the Secretary within 15 business days 
of initiating such correction or removal.
    ``(d) Recordkeeping.--A developer or importer of an in vitro 
clinical test who undertakes a correction or removal of an in vitro 
clinical test which is not required to be reported under this 
subsection shall keep a record of such correction or removal.
    ``(e) Recall Communications.--Upon the voluntary reporting of a 
correction or removal by the developer--
            ``(1) the Secretary shall classify such correction or 
        removal under this section within 15 calendar days; and
            ``(2) not later than 45 calendar days after the developer 
        or other responsible party notifies the Secretary that it has 
        completed a recall action, the Secretary shall provide the 
        developer or other responsible party with a written statement 
        closing the recall action or stating the reasons the Secretary 
        cannot close the recall at that time.
    ``(f) Limitation.--The developer is not required to report a 
correction or removal of an in vitro clinical test based solely on an 
adverse event report under section 587L that captures an error within 
the approved performance standards for such test.
    ``(g) Definitions.--For purposes of this section--
            ``(1) the term `correction' means the repair, modification, 
        adjustment, relabeling, destruction, or inspection (including 
        patient monitoring) of an in vitro clinical test without its 
        physical removal from its point of use to another location, and 
        does not include routine servicing; and
            ``(2) the term `removal' means the physical removal of an 
        in vitro clinical test from its point of use to another 
        location for repair, modification, adjustment, relabeling, 
        destruction, or inspection, and does not include routine 
        servicing.

``SEC. 587N. RESTRICTED IN VITRO CLINICAL TESTS.

    ``(a) Applicability.--
            ``(1) In general.--The Secretary, in issuing an approval of 
        an in vitro clinical test under section 587B of a category 
        described in paragraph (3) may require that such test be 
        restricted to sale, distribution, or use upon such conditions 
        as the Secretary may prescribe under paragraph (2).
            ``(2) Conditions prescribed by the secretary.--The 
        conditions prescribed by the Secretary under this paragraph, 
        with respect to an in vitro clinical test described in 
        paragraph (3), are those conditions which the Secretary 
        determines due to the potentiality for harmful effect of such 
        test (including any resulting absence, delay, or 
        discontinuation of appropriate medical treatment), are 
        necessary to assure the analytical or clinical validity of the 
        test, or the safety of a specimen receptacle.
            ``(3) In vitro clinical tests subject to restrictions.--The 
        restrictions authorized under this section may be applied by 
        the Secretary to any high-risk in vitro clinical test, 
        prescription home-use in vitro clinical test, direct-to-
        consumer in vitro clinical test, or over-the-counter in vitro 
        clinical test.
    ``(b) Labeling and Advertising of a Restricted In Vitro Clinical 
Test.--The label, labeling, and advertising of an in vitro clinical 
test to which restrictions apply under subsection (a) shall bear such 
appropriate statements of the restrictions as the Secretary may 
prescribe in the approval, provisional approval, technology 
certification, or regulation, as applicable.
    ``(c) Requirements Prior to Enactment.--An in vitro clinical test 
that was offered, sold, or distributed as a restricted device prior to 
the enactment date of this subchapter shall continue to comply with the 
applicable restrictions under section 515 or section 520(e) until the 
effective date of restrictions issued under subsection (a).

``SEC. 587O. APPEALS.

    ``(a) Significant Decision.--
            ``(1) In general.--The Secretary shall provide a 
        substantive summary of the scientific and regulatory rationale 
        for any significant decision of the Center for Devices and 
        Radiological Health regarding submission of an application for, 
        or a review of, an in vitro clinical test under section 587B or 
        section 587D or regarding an exemption under section 587A, 
        including documentation of significant controversies or 
        differences of opinion and the resolution of such controversies 
        or differences of opinion.
            ``(2) Provision of documentation.--Upon request, the 
        Secretary shall furnish a substantive summary described in 
        paragraph (1) to the person who has made, or is seeking to 
        make, a submission described in such paragraph.
            ``(3) Application of least burdensome requirements.--The 
        substantive summary required under this subsection shall 
        include a brief statement regarding how the least burdensome 
        requirements were considered and applied consistent with 
        section 587B(j), as applicable.
    ``(b) Review of Significant Decisions.--
            ``(1) Request for supervisory review of significant 
        decision.--Any person may request a supervisory review of the 
        significant decision described in subsection (a)(1). Such 
        review may be conducted at the next supervisory level or higher 
        above the agency official who made the significant decision.
            ``(2) Submission of request.--A person requesting a 
        supervisory review under paragraph (1) shall submit such 
        request to the Secretary not later than 30 days after the 
        decision for which the review is requested and shall indicate 
        in the request whether such person seeks an in-person meeting 
        or a teleconference review.
            ``(3) Timeframe.--The Secretary shall schedule an in-person 
        or teleconference review, if so requested, not later than 30 
        days after such request is made. The Secretary shall issue a 
        decision to the person requesting a review under this 
        subsection not later than 45 days after the request is made 
        under paragraph (1), or, in the case of a person who requests 
        an in-person meeting or teleconference, 30 days after such 
        meeting or teleconference.
    ``(c) Advisory Panels.--The process established under subsection 
(a) shall permit the appellant to request review by an advisory 
committee established under section 513 or 587G. The Secretary shall 
provide a response to an appellant under this subsection not later than 
45 days after the requested advisory committee is convened.

``SEC. 587P. ACCREDITED PERSONS.

    ``(a) In General.--
            ``(1) Review of applications.--
                    ``(A) Accreditation for application review.--
                Subject to subparagraph (C), during the period 
                beginning on the date of enactment of the Verifying 
                Accurate Leading-edge IVCT Development Act of 2021 and 
                ending 2 years after the date of enactment of such Act, 
                the Secretary shall accredit persons for any of the 
                following purposes:
                            ``(i) Reviewing applications for premarket 
                        approval under section 587B and applications 
                        for technology certification under section 
                        587D.
                            ``(ii) Making recommendations to the 
                        Secretary with respect to an approval of an 
                        application under section 587B or issuance of a 
                        technology certification order under section 
                        587D.
                    ``(B) Requirement regarding review 
                recommendations.--
                            ``(i) In general.--In making a 
                        recommendation to the Secretary under this 
                        section, an accredited person shall notify the 
                        Secretary in writing of the reasons for the 
                        recommendation concerning the application.
                            ``(ii) Time period for review.--Not later 
                        than 30 calendar days after the date on which 
                        the Secretary is notified of a recommendation 
                        under this section with respect to an 
                        application for premarket approval or 
                        technology certification, the Secretary shall 
                        make a determination with respect to the 
                        application.
                    ``(C) Lack of applications within 2-year 
                timeframe.--If the Secretary does not receive 
                applications from persons that meet the criteria under 
                subsection (c) within such period, the Secretary--
                            ``(i) may accredit persons under this 
                        paragraph after the 2-year period described in 
                        subparagraph (A); and
                            ``(ii) shall issue a public notice on the 
                        website of the Food and Drug Administration 
                        calling for applications for such 
                        accreditation.
            ``(2) Inspections.--
                    ``(A) Accreditation for inspections.--Subject to 
                subparagraph (B), during the period beginning on the 
                date of enactment of the Verifying Accurate Leading-
                edge IVCT Development Act of 2021 and ending 2 years 
                after the date of enactment of such Act, the Secretary 
                shall accredit persons for the purpose of conducting 
                inspections of in vitro clinical test developers and 
                other persons required to register pursuant to section 
                587I.
                    ``(B) Lack of applications within 2-year 
                timeframe.--If no persons who meet the criteria for 
                such accreditation apply during the 2-year period 
                described in subparagraph (A), the Secretary--
                            ``(i) may accredit persons under this 
                        subparagraph after such period; and
                            ``(ii) shall issue a public notice on the 
                        website of the Food and Drug Administration 
                        calling for applications for such 
                        accreditation.
                    ``(C) Effect of accreditation.--
                            ``(i) In general.--Persons accredited under 
                        subparagraph (A) to conduct inspections, when 
                        conducting such inspections, shall record in 
                        writing their specific observations and shall 
                        present their observations to the designated 
                        representative of the inspected establishment.
                            ``(ii) Inspection report requirements.--
                        Each person accredited under this paragraph 
                        shall prepare and submit to the Secretary an 
                        inspection report in a form and manner 
                        designated by the Secretary for conducting 
                        inspections, taking into consideration the 
                        goals of international harmonization of quality 
                        systems standards. Any official classification 
                        of the inspection shall be determined by the 
                        Secretary. Any statement or representation made 
                        by an employee or agent of an establishment to 
                        a person accredited to conduct inspections 
                        shall be subject to section 1001 of title 18, 
                        United States Code.
                    ``(D) Savings clause.--Nothing in this section 
                affects the authority of the Secretary to inspect any 
                in vitro clinical test developer or other person 
                registered under section 587I.
                    ``(E) Inspection limitations.--The Secretary shall 
                ensure that inspections carried out under this section 
                are not duplicative of inspections carried out under 
                section 353 of the Public Health Service Act. 
                Inspections under this section shall be limited to the 
                data and information necessary--
                            ``(i) for routine surveillance activities 
                        associated with applications under sections 
                        587B and 587D; or
                            ``(ii) to meet the requirements to receive 
                        premarket approval under section 587B or a 
                        technology certification order under section 
                        587D, as applicable.
    ``(b) Accreditation.--
            ``(1) Accreditation program.--
                    ``(A) In general.--The Secretary may provide for 
                accreditation under this section through programs 
                administered by the Food and Drug Administration, by 
                other non-Federal government agencies, or by qualified 
                nongovernmental organizations. A person may be 
                accredited for the review of both applications 
                submitted under sections 587B and 587D as described in 
                subsection (a)(1)(A) and to conduct inspection 
                activities under subsection (a)(2)(A), or for a subset 
                of such review or activities.
                    ``(B) Eligible persons.--Not later than 180 days 
                after the date of enactment of the Verifying Accurate 
                Leading-edge IVCT Development Act of 2021, the 
                Secretary shall issue draft guidance on the criteria 
                that the Secretary will use to accredit or deny 
                accreditation to a person who requests such 
                accreditation under subsection (a), and not later than 
                one year after the close of the comment period for the 
                draft guidance issued in this section, issue final 
                guidance.
                    ``(C) Requirements.--
                            ``(i) In general.--The Secretary shall not 
                        accredit or maintain accreditation for a person 
                        unless such person meets the minimum 
                        qualifications required under subsection (c).
                            ``(ii) Scope of accreditation.--The 
                        accreditation of a person under this section 
                        shall specify the particular activities under 
                        subsection (a) for which such person is 
                        accredited.
                    ``(D) Public list.--The Secretary shall publish on 
                the website of the Food and Drug Administration a list 
                of persons who are accredited under this section. Such 
                list shall be updated on at least a monthly basis. The 
                list shall specify the particular activity or 
                activities under this section for which the person is 
                accredited.
            ``(2) Accreditation process.--
                    ``(A) Accreditation process guidance.--The 
                Secretary shall--
                            ``(i) not later than 180 days after the 
                        date of enactment of the Verifying Accurate 
                        Leading-edge IVCT Development Act of 2021, 
                        issue draft guidance specifying the process for 
                        submitting a request for each type of 
                        accreditation and reaccreditation under this 
                        section, including the form and content of 
                        information to be submitted in such a request; 
                        and
                            ``(ii) not later than 1 year after the 
                        close of the comment period for the draft 
                        guidance, issue final guidance.
                    ``(B) Response to request.--The Secretary shall 
                respond to a request for accreditation or 
                reaccreditation within 60 calendar days of the receipt 
                of the request. The Secretary's response may be to 
                accredit or reaccredit the person, to deny 
                accreditation, or to request additional information in 
                support of the request. If the Secretary requests 
                additional information, the Secretary shall respond 
                within 60 calendar days of receipt of such additional 
                information to accredit or deny the accreditation.
                    ``(C) Type of accreditation.--The accreditation or 
                reaccreditation of a person shall specify the 
                particular activity or activities under subsection (a) 
                for which such person is accredited, and shall include 
                any limitation to certain eligible in vitro clinical 
                tests.
                    ``(D) Audit.--The Secretary may audit the 
                performance of persons accredited under this section 
                for purposes of ensuring that such persons continue to 
                meet the published criteria for accreditation, and may 
                modify the scope or particular activities for which a 
                person is accredited if the Secretary determines that 
                such person fails to meet one or more criteria for 
                accreditation.
                    ``(E) Suspension or withdrawal.--The Secretary may 
                suspend or withdraw accreditation of any person 
                accredited under this section, after providing notice 
                and an opportunity for an informal hearing, when such 
                person is substantially not in compliance with the 
                requirements of this section or the published criteria 
                for accreditation, or poses a threat to public health, 
                or fails to act in a manner that is consistent with the 
                purposes of this section.
                    ``(F) Reaccreditation.--Accredited persons may be 
                initially accredited for up to 4 years. After 
                expiration of such initial period, persons may be 
                reaccredited for unlimited additional 4-year periods, 
                as determined by the Secretary.
    ``(c) Qualifications of Accredited Persons.--
            ``(1) Eligibility.--An accredited person, at a minimum, 
        shall--
                    ``(A) not be an employee of the Federal Government;
                    ``(B) not engage in the activities of a developer, 
                as defined in section 587(7);
                    ``(C) not be a person required to register under 
                section 587I, unless such person has established 
                sufficient processes and protocols to separate 
                activities to develop in vitro clinical tests and the 
                activities for which such person would be accredited 
                under subsection (a) and discloses applicable 
                information under this section;
                    ``(D) not be owned or controlled by, and shall have 
                no organizational, material or financial affiliation 
                with, an in vitro clinical test developer or other 
                person required to register under section 587I;
                    ``(E) be a legally constituted entity permitted to 
                conduct the activities for which it seeks 
                accreditation;
                    ``(F) ensure that the operations of such person are 
                in accordance with generally accepted professional and 
                ethical business practices; and
                    ``(G) include in its request for accreditation a 
                commitment to, at the time of accreditation and at any 
                time it is performing activities pursuant to this 
                section--
                            ``(i) certify that the information reported 
                        to the Secretary accurately reflects the data 
                        or protocol reviewed, and the documented 
                        inspection findings, as applicable;
                            ``(ii) limit work to that for which 
                        competence and capacity are available;
                            ``(iii) treat information received or 
                        learned, records, reports, and recommendations 
                        as proprietary information of the person 
                        submitting such information; and
                            ``(iv) in conducting the activities for 
                        which the person is accredited in respect to a 
                        particular in vitro clinical test, protect 
                        against the use of any employee or consultant 
                        who has a financial conflict of interest 
                        regarding that in vitro clinical test.
            ``(2) Waiver.--The Secretary may waive any requirements in 
        subparagraph (A), (B), (C), or (D) of paragraph (1) upon making 
        a determination that such person has implemented other 
        appropriate controls sufficient to ensure a competent and 
        impartial review.
    ``(d) Compensation of Accredited Persons.--
            ``(1) In general.--Compensation of an accredited person who 
        reviews an application for premarket approval submitted under 
        section 587B or an application for technical certification 
        submitted under section 587D shall be determined by agreement 
        between the accredited person and the person who engages the 
        services of the accredited person, and shall be paid by the 
        person who engages such services.
            ``(2) Inspection accreditation.--Compensation of an 
        accredited person who is conducting an inspection under section 
        704 shall be determined by agreement between the accredited 
        person and the person who engages the services of the 
        accredited person, and shall be paid by the person who engages 
        such services.
    ``(e) Cooperative Agreements.--The Secretary is authorized to enter 
into cooperative arrangements with officials of foreign countries to 
ensure that adequate and effective means are available for purposes of 
determining, from time to time, whether in vitro clinical tests 
intended for use in the United States by a person whose facility is 
located outside the United States shall be refused admission on any of 
the grounds set forth in section 801(a).
    ``(f) Information Sharing Agreements.--An accredited person may 
enter into an agreement with a test developer to provide information to 
the comprehensive test information system under section 587T, including 
any requirements under section 587I.

``SEC. 587Q. RECOGNIZED STANDARDS.

    ``(a) In General.--The Secretary may by order establish performance 
standards for an in vitro clinical test or tests with the same 
indication for use to provide reasonable assurance of the analytical 
validity, clinical validity, or as applicable safety, of that in vitro 
clinical test or tests with the same indications for use.
    ``(b) Other Standards.--The Secretary may recognize all or part of 
appropriate standards established by nationally or internationally 
recognized standard development organizations for which a person may 
submit a declaration of conformity in order to meet a requirement under 
this subchapter to which that standard is applicable. In recognizing a 
standard, any person requesting recognition of a standard or seeking to 
use a recognized standard, the Secretary shall follow the processes and 
requirements, in accordance with section 514(c). Standards for in vitro 
diagnostic devices previously recognized under section 514(c) shall be 
considered recognized standards under this section. The application of 
any such consensus standard shall only apply prospectively. The 
Secretary shall issue guidance establishing the criteria and process 
for such recognition and adoption.
    ``(c) Order Process.--In establishing a standard under subsection 
(a), the Secretary shall issue a draft order proposing to establish a 
standard and shall provide for a comment period of not less than 60 
calendar days. The Secretary may seek the recommendation of an advisory 
committee under section 587G concerning a proposed standard either 
prior to or after issuance of a proposed order. After considering the 
comments and within 90 days of the close of the comment period, the 
Secretary shall issue a final order adopting the proposed standard, 
adopting a modification of the proposed standard or terminating the 
proceeding.
    ``(d) Amendment Process.--The procedures established in this 
section or in guidance issued under this section shall apply to 
amendment of an existing standard.

``SEC. 587R. INVESTIGATIONAL USE.

    ``(a) In General.--Except as provided in subsection (c), an in 
vitro clinical test for investigational use shall be exempt from the 
requirements of this subchapter other than sections 587A, 587O, and 
587U.
    ``(b) Regulations.--Not later than 2 years after the date of 
enactment of the Verifying Accurate Leading-edge IVCT Development Act 
of 2021, the Secretary shall promulgate regulations to implement this 
section.
    ``(c) Application for Investigational Use.--
            ``(1) In general.--The following shall apply with respect 
        to in vitro clinical tests for investigational use:
                    ``(A) Streamlining applications submitted under 
                this section.--Requirements with respect to such tests 
                shall be completed in accordance with current, at the 
                time of submitting the application, investigational use 
                requirements for institutional review boards and 
                current processes for any analytical or clinical 
                validation.
                    ``(B) Variation.--The requirements in the 
                regulations promulgated under this section shall take 
                into account variations based on--
                            ``(i) the scope and duration of clinical 
                        testing to be conducted under investigation 
                        that is the subject of such application;
                            ``(ii) the number of human subjects that 
                        are to be involved in such testing;
                            ``(iii) the need to permit changes to be 
                        made in the in vitro clinical test involved 
                        during testing conducted in accordance with a 
                        plan required under paragraph (3)(B); or
                            ``(iv) whether the clinical testing of such 
                        in vitro clinical test is for the purpose of 
                        developing data to obtain approval to offer 
                        such test.
                    ``(C) Significant risk studies.--In the case of an 
                in vitro clinical test the investigational use of which 
                poses a significant risk, a sponsor of an investigation 
                of such a test seeking an investigational use exemption 
                shall submit to the Secretary an investigational use 
                application with respect to the test in accordance with 
                paragraphs (2) and (3). For purposes of this 
                subparagraph, the term `significant risk' means, with 
                respect to an in vitro clinical test that is a high-
                risk test, and that the use of the test--
                            ``(i) is a use of substantial importance in 
                        performing an activity or activities described 
                        in subsection (ss)(1)(A) for, a serious or 
                        life-threatening disease or condition without 
                        confirmation of the diagnosis by a medically 
                        established means;
                            ``(ii) requires an invasive sampling 
                        procedure that presents a significant risk to 
                        the human subject; or
                            ``(iii) otherwise presents a reasonably 
                        foreseeable serious risk to the health of a 
                        human subject.
                    ``(D) Non-significant risk tests.--In the case of 
                an in vitro clinical test, the investigational use of 
                which does not pose a significant risk--
                            ``(i) the sponsor of such investigation 
                        shall--
                                    ``(I) conduct such investigation in 
                                compliance with an investigational plan 
                                specified in paragraph (5) and labeling 
                                specified in paragraph (3)(A)(ii);
                                    ``(II) ensure each investigator 
                                obtains informed consent under part 50 
                                of title 21, Code of Federal 
                                Regulations (or any successor 
                                regulations), subject to the exceptions 
                                set forth in paragraphs (5)(A)(iii) and 
                                (5)(B);
                                    ``(III) submit a listing to the 
                                Secretary of such investigation; and
                                    ``(IV) maintain records with 
                                respect to all requirements in this 
                                subparagraph; and
                            ``(ii) the sponsor may rely on any 
                        exception or exemption identified in paragraph 
                        (5)(B) or as established by the Secretary in 
                        regulations issued under subsection (b).
            ``(2) Application content.--An investigational use 
        application shall be submitted in such time and manner and 
        contain such information as the Secretary may require in 
        regulation, and shall include an investigational plan for 
        proposed clinical testing and assurances that the sponsor 
        submitting the application will--
                    ``(A) establish and maintain records relevant to 
                the investigation of such in vitro clinical test; and
                    ``(B) submit to the Secretary annual reports of 
                data obtained as a result of the investigational use of 
                the in vitro clinical test during the period covered by 
                the exemption that the Secretary reasonably determines 
                will enable the Secretary--
                            ``(i) to ensure compliance with the 
                        conditions for the exemption specified in 
                        paragraph (3);
                            ``(ii) to review the progress of the 
                        investigation involved; and
                            ``(iii) to evaluate the analytical validity 
                        and clinical validity of such test.
            ``(3) Conditions for exemption.--
                    ``(A) In general.--A request for an investigational 
                use exemption with respect to significant risk tests 
                shall be granted only if each of the following 
                conditions is met:
                            ``(i) The risks to the subjects of the in 
                        vitro clinical test are outweighed by the 
                        anticipated benefits to the subjects and the 
                        importance of the knowledge to be gained, and 
                        adequate assurance of informed consent is 
                        provided in accordance with paragraph 
                        (5)(A)(iii).
                            ``(ii) The proposed labeling for the in 
                        vitro clinical test involved clearly and 
                        conspicuously states `For investigational use'.
                            ``(iii) Such other requirements the 
                        Secretary determines to be necessary for the 
                        protection of the public health and safety as 
                        long as the requirements do not unduly delay 
                        investigation after finding that the results of 
                        such investigation establish sufficient data to 
                        support clinical or analytical validity.
                    ``(B) Certain significant risk in vitro clinical 
                tests for an unmet need.--As a condition for granting 
                an exemption under this paragraph, the Secretary shall 
                not impose a limit on the sample size for a significant 
                risk in vitro clinical test that meets the requirements 
                of section 587C, as long as such test is developed 
                within a laboratory that is certified to conduct high-
                complexity testing under section 353 of the Public 
                Health Service Act.
            ``(4) Coordination with investigational new drug 
        applications.--Any requirement for the submission of a report 
        to the Secretary pursuant to a request for an investigational 
        new drug exemption involving an in vitro clinical test shall 
        supersede the reporting requirement in paragraph (2)(B), but 
        only to the extent the requirement with respect to the request 
        for exemption with respect to the drug is duplicative of the 
        reporting requirement under such paragraph.
            ``(5) Investigation plan requirements.--
                    ``(A) In general.--With respect to an 
                investigational plan submitted under paragraph (2)(A), 
                the sponsor submitting such plan shall--
                            ``(i) in the case of such a plan submitted 
                        to an institutional review committee, promptly 
                        notify the Secretary of the approval or the 
                        suspension or termination of the approval of 
                        such plan by an institutional review committee;
                            ``(ii) in the case of an in vitro clinical 
                        test made available to investigators for 
                        clinical testing, assurance that all 
                        investigators will comply with this section, 
                        regulations promulgated or revised under this 
                        section, and applicable human subjects 
                        regulations; and
                            ``(iii) submit an assurance to the 
                        Secretary that informed consent will be 
                        obtained from each human subject (or the 
                        representative of such subject) of proposed 
                        clinical testing involving such in vitro 
                        clinical test, except in the case that--
                                    ``(I) there is a life-threatening 
                                situation involving the human subject 
                                of such testing which necessitates the 
                                use of such in vitro clinical test;
                                    ``(II) it is not feasible to obtain 
                                informed consent from the subject; and
                                    ``(III) there is not sufficient 
                                time to obtain such consent from a 
                                representative of such subject.
                    ``(B) Exception.--The informed consent of human 
                subjects shall not be required with respect to clinical 
                testing conducted as part of an investigation, if--
                            ``(i) the clinical testing uses remnants of 
                        specimens collected for routine clinical care 
                        or analysis that would have been discarded, 
                        leftover specimens that were previously 
                        collected for other research purposes, or 
                        specimens obtained from specimen repositories;
                            ``(ii) the identity of the subject of the 
                        specimen is not known to, and may not readily 
                        be ascertained by, the investigator or any 
                        other individual associated with the 
                        investigation, including the sponsor;
                            ``(iii) any clinical information that 
                        accompanies the specimens does not make the 
                        specimen source identifiable to the 
                        investigator or any other individual associated 
                        with the investigation, including the sponsor;
                            ``(iv) the individuals caring for the human 
                        subjects as patients are different from, and do 
                        not share information about the patient with, 
                        the individuals conducting the investigation; 
                        and
                            ``(v) the specimens are provided to the 
                        investigators without personally identifiable 
                        information and the supplier of the specimens 
                        has established policies and procedures to 
                        prevent the release of personally identifiable 
                        information.
    ``(d) Review of Applications.--
            ``(1) In general.--The Secretary may issue an order 
        approving an investigation as proposed, approving it with 
        conditions or modifications, or disapproving it.
            ``(2) Failure to act.--Unless the Secretary, not later than 
        the date that is 30 calendar days after the date of the 
        submission of an investigational use exemption request that 
        meets the requirements of subsection (c)(2), issues an order 
        under subsection (d)(1) and notifies the sponsor submitting the 
        application, the request shall be treated as granted as of such 
        date without further action by the Secretary.
            ``(3) Disapproval.--The Secretary may deny an 
        investigational use request submitted under this subsection if 
        the Secretary determines that the investigation with respect to 
        which the request is submitted does not conform to the 
        requirements of subsection (c)(3). A listing of such denial 
        submitted to the sponsor with respect to such a request shall 
        contain the order of disapproval and a complete statement of 
        the reasons for the Secretary's denial of the request.
    ``(e) Withdrawal of Approval.--
            ``(1) In general.--The Secretary may, by administrative 
        order, withdraw an exemption granted under this section with 
        respect to an in vitro clinical test, including an exemption 
        granted based on the Secretary's failure to act pursuant to 
        subsection (d)(2), if the Secretary determines that the test 
        does not meet the applicable conditions under subsection (c)(3) 
        for such exemption.
            ``(2) Opportunity to be heard.--
                    ``(A) In general.--Subject to subparagraph (B), an 
                order withdrawing the exemption granted under this 
                section may be issued only after the Secretary provides 
                the applicant or sponsor of the test with an 
                opportunity for an informal hearing.
                    ``(B) Exception.--An order referred to in 
                subparagraph (A) with respect to an exemption granted 
                under this subsection may be issued on a preliminary 
                basis before the provision of an opportunity for an 
                informal hearing if the Secretary determines that the 
                continuation of testing under the exemption will result 
                in an unreasonable risk to the public health. The 
                Secretary will provide an opportunity for an informal 
                hearing promptly following any preliminary action under 
                this subparagraph.
    ``(f) Changes.--
            ``(1) In general.--The regulations promulgated under 
        subsection (b) shall provide, with respect to an in vitro 
        clinical test for which an exemption under this subsection is 
        in effect, procedures and conditions under which the changes to 
        the test are allowed without the additional determination on a 
        request for an exemption or submission of a supplement to such 
        a request. Such regulations shall provide that such a change 
        may be made if--
                    ``(A) the sponsor or applicant determines, on the 
                basis of credible information (as defined by the 
                Secretary) that the change meets the conditions 
                specified in paragraph (2); and
                    ``(B) the sponsor or applicant submits to the 
                Secretary, not later than 5 calendar days after making 
                the change, a notice of the change.
            ``(2) Conditions.--The conditions specified in this 
        paragraph are that--
                    ``(A) in the case of developmental changes to an in 
                vitro clinical test (including manufacturing changes), 
                the changes--
                            ``(i) do not constitute a significant 
                        change in design or in basic principles of 
                        operation;
                            ``(ii) do not affect the rights, safety, or 
                        welfare of the human subjects (if any) involved 
                        in the investigation; and
                            ``(iii) are made in response to information 
                        gathered during the course of an investigation; 
                        and
                    ``(B) in the case of changes to clinical protocols 
                applicable to the test, the changes do not affect--
                            ``(i) the validity of data or information 
                        resulting from the completion of an approved 
                        clinical protocol;
                            ``(ii) the scientific soundness of a plan 
                        submitted under subsection (c)(5); or
                            ``(iii) the rights, safety, or welfare of 
                        the human subjects (if any) involved in the 
                        investigation.
    ``(g) Clinical Hold.--
            ``(1) In general.--At any time, the Secretary may impose a 
        clinical hold with respect to an investigation of an in vitro 
        clinical test if the Secretary makes a determination described 
        in paragraph (2). The Secretary shall, in imposing such 
        clinical hold, specify the basis for the clinical hold, 
        including the specific information available to the Secretary 
        which served as the basis for such clinical hold, and confirm 
        such determination in writing. The applicant or sponsor may 
        immediately appeal any such determination pursuant to section 
        587O.
            ``(2) Determination.--For purposes of paragraph (1), a 
        determination described in this subparagraph with respect to a 
        clinical hold is a determination that--
                    ``(A) the in vitro clinical test involved 
                represents an unreasonable risk to the safety of the 
                persons who are the subjects of the clinical 
                investigation, taking into account the qualifications 
                of the clinical investigators, information about the in 
                vitro clinical test, the design of the clinical 
                investigation, the condition for which the in vitro 
                clinical test is to be investigated, and the health 
                status of the subjects involved;
                    ``(B) the clinical hold should be issued for such 
                other reasons as the Secretary may by regulation 
                establish; or
                    ``(C) any written request to the Secretary from the 
                sponsor of an investigation that a clinical hold be 
                removed shall receive a decision, in writing and 
                specifying the reasons therefor, within 30 days after 
                receipt of such request. Any such request shall include 
                sufficient information to support the removal of such 
                clinical hold.

``SEC. 587S. COLLABORATIVE COMMUNITIES FOR IN VITRO CLINICAL TESTS.

    ``(a) In General.--
            ``(1) For the purposes of facilitating community solutions 
        and decision making with respect to in vitro clinical tests, 
        the Secretary may participate in collaborative communities 
        comprised of public and private participants that may provide 
        recommendations and other advice to the Secretary on the 
        development and regulation of in vitro clinical tests.
            ``(2) A collaborative community under this section shall 
        have broad representation of interested private and public-
        sector stakeholder communities and may include patients, care 
        partners, academics, health care professionals, health care 
        systems, payors, Federal and State agencies, entities 
        responsible for accrediting clinical laboratories, 
        international regulatory bodies, test developers, or other 
        interested entities or communities.
    ``(b) Guidance.--The Secretary shall issue a draft guidance not 
later than 180 days after the date of enactment of the Verifying 
Accurate Leading-edge IVCT Development Act of 2021, addressing the 
participation process and framework to build consensus, and how the 
Secretary may consider, review, and implement recommendations under 
subsection (c).
    ``(c) Recommendations.--A collaborative community for in vitro 
clinical tests may make recommendations to the Secretary on matters 
including--
            ``(1) mitigating measures for in vitro clinical tests;
            ``(2) standards development activities and performance 
        standards for in vitro clinical tests or groups of such tests;
            ``(3) scientific and clinical evidence to support new 
        claims for in vitro clinical tests;
            ``(4) new technologies and methodologies related to in 
        vitro clinical tests;
            ``(5) stakeholder communication and engagement; and
            ``(6) development of effective policies and processes, 
        including to develop tests, and to regulate such tests in 
        accordance with least burdensome requirements described in 
        section 587B(j).
    ``(d) Use by Secretary.--
            ``(1) In general.--The Secretary may adopt recommendations 
        made under subsection (b), or otherwise incorporate the 
        feedback from collaborative communities into regulatory 
        decision making, through rulemaking or guidance, as 
        appropriate.
            ``(2) Clarification.--The Secretary is not required to 
        adopt recommendations submitted by collaborative communities.
    ``(e) Transparency.--The Secretary shall--
            ``(1) publish on the website of the Food and Drug 
        Administration matters for which it is seeking comments or 
        recommendations, in a timely manner;
            ``(2) maintain a list of all collaborative communities in 
        which the Secretary participates and make such list available 
        on the website of the Food and Drug Administration; and
            ``(3) post on the website of the Food and Drug 
        Administration at least once every year a report on the 
        recommendations it has adopted and recommendations it has not 
        adopted from collaborative communities.
    ``(f) Participation.--The Secretary may participate in a 
collaborative community only if such community requires members to 
disclose conflicts of interest and has established a process to address 
conflicts of interest.
    ``(g) Exemption.--The collaborative communities established and 
used in accordance with this section shall be exempt from the Federal 
Advisory Committee Act (5 U.S.C. App.).

``SEC. 587T. COMPREHENSIVE TEST INFORMATION SYSTEM.

    ``(a) Purpose.--For the purposes of improving the transparency of 
information on in vitro clinical tests and allowing patients and health 
care providers better access to information about in vitro clinical 
tests, the Secretary shall establish a comprehensive test information 
system.
    ``(b) Establishment.--Not later than 2 years after the date of 
enactment of the Verifying Accurate Leading-edge IVCT Development Act 
of 2021, the Secretary shall make available a comprehensive test 
information system for in vitro clinical tests that is designed to--
            ``(1) provide a transparent interface on the website of the 
        Food and Drug Administration for stakeholders, to the extent 
        permitted by applicable law, to access the--
                    ``(A) regulatory pathway designation information 
                for each in vitro clinical test or tests with the same 
                indications for use;
                    ``(B) registration and listing information provided 
                by developers under section 587I, including the use of 
                a link for labels;
                    ``(C) adverse event reports submitted under section 
                587L;
                    ``(D) reports of corrections and removals submitted 
                under section 587M; and
                    ``(E) other information pertaining to an in vitro 
                clinical test or tests with the same indications for 
                use, as the Secretary determines appropriate; and
            ``(2) provide a secure portal for electronic submission, 
        including applications and other in vitro clinical test 
        submissions, registration and listing information, and adverse 
        event reports.
    ``(c) Submission Function.--The comprehensive test information 
system shall serve as the electronic submission service for test 
developers submitting information for applications under sections 587B 
and 587D.

``SEC. 587U. PREEMPTION.

    ``(a) In General.--No State, Tribal, or local government (or 
political subdivision thereof) may establish or continue in effect any 
requirement related to the development, manufacture, labeling, 
distribution, sale, or use of an in vitro clinical test that is 
different from, or in addition to, the requirements of this subchapter.
    ``(b) Exceptions.--Subsection (a) shall not be construed to affect 
the authority of a State, Tribal, or local government--
            ``(1) to license laboratory personnel, health care 
        practitioners, or health care facilities or to regulate any 
        aspect of a health care practitioner-patient relationship; or
            ``(2) to enforce laws of general applicability, such as 
        zoning laws, environmental laws, labor laws, and general 
        business laws.
    ``(c) Clarification.--This section shall not be construed to shift 
liability to health care practitioners or other users.

``SEC. 587V. ADULTERATION.

    ``An in vitro clinical test shall be deemed to be adulterated:
            ``(1) If it consists in whole or in part of any filthy, 
        putrid, or decomposed substance.
            ``(2) If it has been developed, prepared, packed, or held 
        under insanitary conditions whereby it may have been 
        contaminated with filth, or whereby it may have been rendered 
        injurious to health.
            ``(3) If its container or package is composed, in whole or 
        in part, of any poisonous or deleterious substance which may 
        render the contents injurious to health.
            ``(4) If it bears or contains, for purposes of coloring 
        only, a color additive which is unsafe within the meaning of 
        section 721(a).
            ``(5) If its analytical or clinical validity, or with 
        respect to a specimen receptacle, its safety, or its strength, 
        purity, or quality, differs from or falls below that which it 
        purports or is represented to possess.
            ``(6) If it is required to be, declared to be, purports to 
        be, or is represented as being, in conformity with any 
        performance standard established or recognized under section 
        587Q and is not in all respects in conformity with such 
        standard.
            ``(7) If it is required to be in conformity with a 
        mitigating measure established under section 587E and is not in 
        all respects in conformity with such mitigating measure.
            ``(8) If it fails to have an approved premarket application 
        under section 587B unless such in vitro clinical test can be 
        lawfully offered--
                    ``(A) for clinical use pursuant to an exemption 
                under section 587A;
                    ``(B) for emergency use pursuant to an 
                authorization under section 564; or
                    ``(C) for investigational use pursuant to section 
                587R.
            ``(9) If it is not in conformity with any condition 
        established under section 587B, 587D, or 564.
            ``(10) If it purports to be an in vitro clinical test that 
        is offered for clinical use subject to an exemption under 
        section 587A and it fails to meet or maintain any criteria, 
        condition, or requirement of such exemption.
            ``(11) If it has been granted an exemption under section 
        587R for investigational use, and the person granted such 
        exemption or any investigator who uses such in vitro clinical 
        test under such exemption fails to comply with a requirement 
        prescribed by or under such section.
            ``(12) If it fails to meet the quality requirements 
        prescribed in or established under section 587J (as 
        applicable), or the methods used in, or facilities or controls 
        used for, its development, manufacture, packing, storage, or 
        installation are not in conformity with applicable requirements 
        established under such section.
            ``(13) If it has been developed, manufactured, processed, 
        packed or held in any establishment, factory, or warehouse and 
        the owner, operator or agent of such establishment, factory, or 
        warehouse delays, denies, or limits an inspection, or refuses 
        to permit entry or inspection.
            ``(14) If it is not in compliance with any restriction 
        required under section 587N.

``SEC. 587W. MISBRANDING.

    ``An in vitro clinical test shall be deemed to be misbranded:
            ``(1) If its labeling is false or misleading in any 
        particular.
            ``(2) If in a package form unless it bears a label 
        containing--
                    ``(A) the name and place of business of the test 
                developer, manufacturer, packer, or distributor; and
                    ``(B) an accurate statement of the quantity of 
                contents in terms of weight, measure, or numerical 
                count with respect to small packages, unless an 
                exemption is granted by the Secretary by the issuance 
                of guidance.
            ``(3) If any word, statement, or other information required 
        by or under authority of this Act to appear on the label or 
        labeling, including a test report, is not prominently placed 
        thereon with such conspicuousness (as compared with other 
        words, statements, designs, or devices, in the labeling) and in 
        such terms as to render it likely to be read and understood by 
        the ordinary individual under customary conditions of purchase 
        and use.
            ``(4) Unless its labeling bears adequate directions for use 
        and such adequate warnings as are necessary for the protection 
        of users of the in vitro clinical test and recipients of the 
        results of such in vitro clinical test, including patients, 
        consumers, donors, and related health care professionals. 
        Required labeling for in vitro clinical tests intended for use 
        in health care facilities or by a health care professional may 
        be made available solely by electronic means, provided that the 
        labeling complies with all applicable requirements of law, and 
        that the test developer, manufacturer, or distributor affords 
        such users the opportunity to request the labeling in paper 
        form, and after such request, promptly provides the requested 
        information without additional cost.
            ``(5) If it causes serious or adverse health consequences 
        or death, including through absence, delay, or discontinuation 
        in diagnosis or treatment, when used in the manner prescribed, 
        recommended, or suggested in the labeling thereof.
            ``(6) If it was developed or manufactured in an 
        establishment not duly registered under section 587I or it was 
        not included in a listing under section 587I, in accordance 
        with timely reporting requirements under this subchapter.
            ``(7) In the case of any in vitro clinical test subject to 
        restrictions under section 587N, (1) if its advertising is 
        false or misleading in any particular, (2) if it is offered for 
        clinical use, sold, distributed, or used in violation of such 
        restrictions, or (3) unless the test developer, manufacturer, 
        or distributor includes in all advertisements and other 
        descriptive printed matter that such person issues or causes to 
        be issued, a brief statement of the intended uses of the in 
        vitro clinical test and relevant warnings, precautions, side 
        effects, and contraindications. This subsection shall not be 
        applicable to any printed matter that the Secretary determines 
        to be labeling as defined in section 201(m) or section 587K.
            ``(8) If it was subject to a mitigating measure established 
        under section 587E, unless it bears such labeling as may be 
        prescribed in such mitigating measure.
            ``(9) If it was subject to a standard established under 
        section 587Q, unless it bears such labeling as may be 
        prescribed in such standard.
            ``(10) Unless it bears such labeling as may be prescribed 
        by or established under an applicable labeling requirement 
        under this Act.
            ``(11) If there was a failure or refusal to comply with any 
        requirement prescribed under section 587I or 587X, or to comply 
        with a requirement under section 587Y, or to provide any 
        report, material, or information required under this 
        subchapter.

``SEC. 587X. POSTMARKET SURVEILLANCE.

    ``(a) In General.--
            ``(1) In general.--In addition to other applicable 
        requirements under this Act, the Secretary may issue an order 
        requiring a developer to conduct postmarket surveillance of a 
        single in vitro clinical test as a condition of approval under 
        section 587B.
            ``(2) Exempt tests.--The Secretary may order postmarket 
        surveillance for tests exempt pursuant to section 587A for 
        which the failure of the in vitro clinical test to meet the 
        applicable standard for approval is likely to result in serious 
        or adverse health consequences or death from use of the single 
        in vitro clinical test.
            ``(3) Consideration.--In determining whether to require a 
        developer to conduct postmarket surveillance of an in vitro 
        clinical test, the Secretary shall take into consideration the 
        benefits and risks for the patient and the least burdensome 
        principles under section 587B.
    ``(b) Surveillance Approval.--
            ``(1) Each developer required to conduct a surveillance of 
        an in vitro clinical test shall submit, within 30 days of 
        receiving an order from the Secretary, a plan for the required 
        surveillance. The Secretary, within 60 days of the receipt of 
        such plan, shall determine if the person designated to conduct 
        the surveillance has the appropriate qualifications and 
        experience to undertake such surveillance and if the plan will 
        result in useful data that can reveal unforeseen adverse events 
        or other information necessary to protect the health of 
        patients or the public.
            ``(2) The developer shall commence surveillance under this 
        section not later than 15 months after the day on which the 
        Secretary orders such postmarket surveillance, unless the 
        Secretary determines more time is needed to commence 
        surveillance.
            ``(3) The Secretary may order a prospective surveillance 
        period of up to 3 years. Any determination by the Secretary 
        that a longer period is necessary shall be made by mutual 
        agreement between the Secretary and the manufacturer or, if no 
        agreement can be reached, after the completion of a dispute 
        resolution process.

``SEC. 587Y. ELECTRONIC FORMAT FOR SUBMISSIONS.

    ``(a) In General.--All presubmissions and submissions to the Food 
and Drug Administration with respect to an in vitro clinical test shall 
include an electronic copy of such presubmission or submission, and, 
with respect to the information required under sections 587B and 587D, 
shall utilize the system described in section 587T.
    ``(b) Electronic Format.--Beginning on such date as the Secretary 
specifies in final guidance issued under subsection (c), presubmissions 
and submissions for in vitro clinical tests (and any appeals of action 
taken by the Secretary with respect to such presubmissions and 
submissions) shall be submitted solely in such electronic format as 
specified by the Secretary in such guidance.
    ``(c) Guidance.--The Secretary shall issue guidance implementing 
this section. In such guidance, the Secretary may--
            ``(1) provide standards for the electronic copy required 
        under subsection (a) or the submission in electronic format 
        required under subsection (b);
            ``(2) set forth criteria for waivers of or exemptions from 
        the requirements of subsection (a) or (b); and
            ``(3) provide any other information for the efficient 
        implementation and enforcement of this section.

``SEC. 587Z. POSTMARKET REMEDIES.

    ``(a) Safety Notice.--
            ``(1) In general.--If the Secretary determines that an in 
        vitro clinical test presents an unreasonable risk of 
        substantial harm to the public health, and notification under 
        this subsection is necessary to eliminate the unreasonable risk 
        of such harm and no more practicable means is available under 
        the provisions of this Act (other than this section) to 
        eliminate the risk, the Secretary may issue such order as may 
        be necessary to ensure that adequate safety notice is provided 
        in an appropriate form, by the persons and means best suited 
        under the circumstances, to all health care professionals who 
        prescribe, order, or use the in vitro clinical test and to any 
        other person (including developers, manufacturers, importers, 
        distributors, retailers, and users) who should properly receive 
        such notice.
            ``(2) Notice to individuals.--An order under this 
        subsection shall require that the individuals subject to the 
        risk with respect to which the order is to be issued be 
        included in the persons to be notified of the risk unless the 
        Secretary determines that notice to such individuals would 
        present a greater danger to the health of such individuals than 
        no such notice. If the Secretary makes such a determination 
        with respect to such individuals, the order shall advise the 
        health care professionals who prescribed, ordered, or used the 
        in vitro clinical test provide notification to the individuals 
        for whom the health professionals prescribed, ordered, or used 
        such test, of the risk presented by such in vitro clinical test 
        and of any action which may be taken by or on behalf of such 
        individuals to eliminate or reduce such risk. Before issuing an 
        order under this subsection, the Secretary shall consult with 
        the persons required to give notice under the order.
    ``(b) Repair, Replacement, or Refund.--
            ``(1) Determination after an informal hearing.--
                    ``(A) In general.--If, after affording opportunity 
                for an informal hearing, the Secretary determines 
                that--
                            ``(i) an in vitro clinical test presents an 
                        unreasonable risk of substantial harm to the 
                        public health;
                            ``(ii) there are reasonable grounds to 
                        believe that the in vitro clinical test was not 
                        properly developed or manufactured considering 
                        the state of the art as it existed at the time 
                        of its development or manufacture;
                            ``(iii) there are reasonable grounds to 
                        believe that the unreasonable risk was not 
                        caused by failure of a person other than a 
                        developer, manufacturer, importer, distributor, 
                        or retailer of the in vitro clinical test to 
                        exercise due care in the installation, 
                        maintenance, repair, or use of the in vitro 
                        clinical test; and
                            ``(iv) the notice authorized by subsection 
                        (a) would not by itself be sufficient to 
                        eliminate the unreasonable risk and action 
                        described in paragraph (2) of this subsection 
                        is necessary to eliminate such risk,
                the Secretary may order the developer, manufacturer, 
                importer, or any distributor of such in vitro clinical 
                test, or any combination of such persons, to submit to 
                him within a reasonable time a plan for taking one or 
                more of the actions described in paragraph (2). An 
                order issued under the preceding sentence which is 
                directed to more than one person shall specify which 
                person may decide which action shall be taken under 
                such plan and the person specified shall be the person 
                who the Secretary determines bears the principal, 
                ultimate financial responsibility for action taken 
                under the plan unless the Secretary cannot determine 
                who bears such responsibility or the Secretary 
                determines that the protection of the public health 
                requires that such decision be made by a person 
                (including a health professional or user of the in 
                vitro clinical test) other than the person the 
                Secretary determines bears such responsibility.
                    ``(B) Secretary approval of plan.--Within 30 
                calendar days of issuing an order under subparagraph 
                (A), the Secretary shall approve a plan submitted 
                pursuant to an order issued under subparagraph (A) 
                unless the Secretary determines (after affording 
                opportunity for an informal hearing) that the action or 
                actions to be taken under the plan or the manner in 
                which such action or actions are to be taken under the 
                plan will not assure that the unreasonable risk with 
                respect to which such order was issued will be 
                eliminated. If the Secretary disapproves a plan, the 
                Secretary shall order a revised plan to be submitted 
                within a reasonable time. If the Secretary determines 
                (after affording opportunity for an informal hearing) 
                that the revised plan is unsatisfactory or if no 
                revised plan or no initial plan has been submitted to 
                the Secretary within the prescribed time, the Secretary 
                shall (i) prescribe a plan to be carried out by the 
                person or persons to whom the order issued under 
                subparagraph (A) was directed, or (ii) after affording 
                an opportunity for an informal hearing, by order 
                prescribe a plan to be carried out by a person who is a 
                manufacturer, importer, distributor, or retailer of the 
                in vitro clinical test with respect to which the order 
                was issued but to whom the order under subparagraph (A) 
                was not directed.
            ``(2) Actions on a plan.--The actions which may be taken 
        under a plan submitted under an order issued under paragraph 
        (1) are as follows:
                    ``(A) To repair the in vitro clinical test so that 
                it does not present the unreasonable risk of 
                substantial harm with respect to which the order under 
                paragraph (1)(A) was issued.
                    ``(B) To replace the in vitro clinical test with a 
                like or equivalent test which is in conformity with all 
                applicable requirements of this Act.
                    ``(C) To refund the purchase price of the in vitro 
                clinical test (less a reasonable allowance for use if 
                such in vitro clinical test has been in the possession 
                of the user for one year or more at the time of notice 
                ordered under subsection (a), or at the time the user 
                receives actual notice of the unreasonable risk with 
                respect to which the order was issued under paragraph 
                (1)(A), whichever occurs first).
            ``(3) No charge.--No charge shall be made to any person 
        (other than a developer, manufacturer, importer, distributor or 
        retailer) for using a remedy described in paragraph (2) and 
        provided under an order issued under paragraph (1), and the 
        person subject to the order shall reimburse each person (other 
        than a developer, manufacturer, importer, distributor, or 
        retailer) who is entitled to such a remedy for any reasonable 
        and foreseeable expenses actually incurred by such person in 
        availing himself of such remedy.
    ``(c) Reimbursement.--An order issued under subsection (b)(1)(A) 
with respect to an in vitro clinical test may require any person who is 
a developer, manufacturer, importer, distributor, or retailer of the in 
vitro clinical test to reimburse any other person who is a developer, 
manufacturer, importer, distributor, or retailer of such in vitro 
clinical test for such other person's expenses actually incurred in 
connection with carrying out the order if the Secretary determines such 
reimbursement is required for the protection of the public health. Any 
such requirement shall not affect any rights or obligations under any 
contract to which the person receiving reimbursement or the person 
making such reimbursement is a party.
    ``(d) Recall Authority.--
            ``(1) In general.--If the Secretary finds that there is a 
        reasonable probability that an in vitro clinical test approved 
        under section 587B would cause serious, adverse health 
        consequences or death, including by the absence, delay, or 
        discontinuation of appropriate medical treatment, the Secretary 
        shall issue an order requiring the appropriate person 
        (including the developers, manufacturers, importers, 
        distributors, or retailers of the in vitro clinical test)--
                    ``(A) to immediately cease distribution of such in 
                vitro clinical test; and
                    ``(B) to immediately notify health professionals 
                and user facilities of the order and to instruct such 
                professionals and facilities to cease use of such in 
                vitro clinical test.
            ``(2) Informal hearing.--The order issued under paragraph 
        (1)(A), shall provide the person subject to the order with an 
        opportunity for an informal hearing, to be held not later than 
        10 calendar days after the date of the issuance of the order, 
        on the actions required by the order and on whether the order 
        should be amended to require a recall of such in vitro clinical 
        test. If, after providing an opportunity for such a hearing, 
        the Secretary determines that inadequate grounds exist to 
        support the actions required by the order, the Secretary shall 
        vacate the order.
            ``(3) Amended order.--
                    ``(A) In general.--If, after providing an 
                opportunity for an informal hearing under paragraph 
                (2), the Secretary determines that the order should be 
                amended to include a recall of the in vitro clinical 
                test with respect to which the order was issued, the 
                Secretary shall, except as provided in subparagraph 
                (B), amend the order to require a recall. The Secretary 
                shall specify a timetable in which the recall will 
                occur and shall require periodic reports describing the 
                progress of the recall.
                    ``(B) Requirements.--An amended order under 
                subparagraph (A)--
                            ``(i) shall not include recall of the in 
                        vitro clinical test from individuals;
                            ``(ii) shall not include recall of an in 
                        vitro clinical test from test user facilities 
                        if the Secretary determines that the risk of 
                        recalling such in vitro clinical test from the 
                        facilities presents a greater health risk than 
                        the health risk of not recalling the in vitro 
                        clinical test from use; and
                            ``(iii) shall provide for notice to 
                        individuals subject to the risks associated 
                        with the use of such in vitro clinical test. In 
                        providing the notice required by this clause, 
                        the Secretary may use the assistance of health 
                        professionals who prescribed, ordered, or used 
                        such an in vitro clinical test for individuals.
            ``(4) Clarification.--The remedy provided by this 
        subsection shall be in addition to remedies provided by 
        subsections (b) and (c).''.

SEC. 4. ENFORCEMENT AND OTHER PROVISIONS.

    (a) Prohibited Acts.--Section 301 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 331) is amended--
            (1) in paragraphs (a), (b), (c), (g), (k), (q), (r), and 
        (y), by inserting ``in vitro clinical test,'' after ``device,'' 
        each place it appears;
            (2) in paragraph (y) by inserting ``or 587P'' after 
        ``section 523'' each place it appears; and
            (3) by adding at the end, the following:
    ``(fff)(1) The introduction or delivery for introduction into 
interstate commerce of an in vitro clinical test in violation of 
section 587B(a).
    ``(2) The false, fraudulent, or deceptive claiming for an in vitro 
clinical test of an exemption from the premarket review required under 
section 587B.
    ``(3) When claiming an exemption under section 587A from the 
premarket review required under section 587B, the failure to maintain 
complete and accurate documentation for the exemption as required under 
section 587A or the failure to provide labeling required under section 
587A.
    ``(4) With respect to an in vitro clinical test, the submission of 
any report that is required by or under this Act that is false or 
misleading in any material respect.
    ``(5) The making of a false, fraudulent, or materially deceptive 
analytical or clinical claim for an in vitro clinical test--
            ``(A) in any application, report, or notification submitted 
        to the Secretary under this Act; or
            ``(B) in the labeling or advertising of an in vitro 
        clinical test.
    ``(6) The failure to comply with a condition of approval, 
performance standard, mitigating measure, or restriction established in 
an order approving an application or supplement under section 587B; the 
failure to perform a risk analysis required by section 587B; the 
failure to submit an annual report required under section 587B(k); or 
the failure to complete postmarket studies required under section 587V.
    ``(7) The marketing of an in vitro clinical test in violation of--
            ``(A) an order issued by the Secretary under section 587A; 
        or
            ``(B) any requirement under section 587A.
    ``(8) With respect to technology certification under section 587D, 
the refusal to permit, or unreasonable delay in permitting, an 
inspection authorized under section 587D(f)(3)(G); the failure to 
comply with applicable requirements to submit an application or report 
under section 587D(e); or the failure to comply with applicable 
maintenance requirements under section 587D(h).
    ``(9) The failure to comply with an applicable mitigating measure 
established under section 587E or to maintain the documentation 
required under section 587E(b); or the failure to comply with a 
performance standard established under section 587Q.
    ``(10) The failure to register in accordance with section 587I, the 
failure to provide information required under section 587I(b), or the 
failure to maintain or submit information required under section 
587I(c).
    ``(11) The failure to submit a report required under section 587L 
or 587M; the failure to comply with a restriction imposed under section 
587N; or the failure to comply with labeling and advertising 
requirements under section 587N(b).
    ``(12) The failure to comply with the requirements of section 587P 
(relating to accredited persons).
    ``(13) The failure to comply with any requirement prescribed or 
established under section 587R; the failure to furnish any 
notification, information, material, or report required under section 
587R; or the failure to comply with an order issued under section 
587R.''.
    (b) Penalties.--Section 303(f)(1) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 333(f)(1)) is amended--
            (1) in subparagraph (A), by inserting ``or in vitro 
        clinical tests'' after ``devices''; and
            (2) in subparagraph (B)(i)--
                    (A) by inserting ``, or 587J or 587L,'' after 
                ``520(f)''; and
                    (B) by inserting ``, or who violates section 
                587M(b) with respect to a correction report'' after 
                ``risk to public health''.
    (c) Seizure.--Section 304 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 334) is amended--
            (1) in subsection (a)(2)--
                    (A) by striking ``and'' before ``(E) Any''; and
                    (B) by inserting ``, and (F) Any adulterated or 
                misbranded in vitro clinical test'' after ``tobacco 
                product'';
            (2) in subsection (d)(1), by inserting ``in vitro clinical 
        test,'' after ``device,''; and
            (3) in subsection (g)--
                    (A) in paragraph (1), by inserting ``, in vitro 
                clinical test,'' after ``device'' each place it 
                appears; and
                    (B) in paragraph (2)--
                            (i) in subparagraph (A), by inserting ``, 
                        in vitro clinical test,'' after ``device''; and
                            (ii) in subparagraph (B), by inserting ``or 
                        in vitro clinical test'' after ``device'' each 
                        place it appears.
    (d) Debarment, Temporary Denial of Approval, and Suspension.--
Section 306 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
335a) is amended by adding at the end the following:
    ``(n) In Vitro Clinical Tests; Mandatory Debarment Regarding Third-
Party Inspections and Reviews.--
            ``(1) In general.--If the Secretary finds that a person has 
        been convicted of a felony under section 301(gg), 301(fff)(2), 
        301(fff)(5), or 301(fff)(8), the Secretary shall debar such 
        person from being accredited under section 587P and from 
        carrying out activities under an agreement described in section 
        803(b).
            ``(2) Debarment period.--The Secretary shall debar a person 
        under paragraph (1) for the following periods:
                    ``(A) The period of debarment of a person (other 
                than an individual) shall not be less than 1 year or 
                more than 10 years, but if an act leading to a 
                subsequent debarment under such paragraph occurs within 
                10 years after such person has been debarred under such 
                paragraph, the period of debarment shall be permanent.
                    ``(B) The debarment of an individual shall be 
                permanent.
            ``(3) Termination of debarment; judicial review; other 
        matters.--Subsections (c)(3), (d), (e), (i), (j), and (l)(1) 
        apply with respect to a person (other than an individual) or an 
        individual who is debarred under paragraph (1) to the same 
        extent and in the same manner as such subsections apply with 
        respect to a person who is debarred under subsection (a)(1), or 
        an individual who is debarred under subsection (a)(2), 
        respectively.''.
    (e) Judicial Review.--Section 517(a) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360g(a)) is amended--
            (1) in paragraph (8), by striking ``or'' at the end;
            (2) in paragraph (9), by inserting ``or'' after the comma 
        at the end; and
            (3) before the matter that follows paragraph (9), by 
        inserting the following:
            ``(10) an order issued pursuant to section 587B, 587D, 
        587R, or 587S,''.
    (f) Expanded Access to Unapproved Therapies and Diagnostics.--
Section 561 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360bbb) is amended--
            (1) in subsections (a) through (d)--
                    (A) by striking ``or investigational devices'' each 
                place it appears and inserting ``, investigational 
                devices, or investigational in vitro clinical tests''; 
                and
                    (B) by striking ``or investigational device'' each 
                place it appears (other than the second such place in 
                paragraph (3)(A)) and inserting ``, investigational 
                device, or investigational in vitro clinical test'';
            (2) in subsection (b)(4) by striking ``or 520(g)'' and 
        inserting ``, 520(g), or 587R'' each place it appears;
            (3) in subsection (c)--
                    (A) by amending the subsection heading to read: 
                ``Treatment Investigational New Drug Applications, 
                Treatment Investigational Device Exemptions, and 
                Treatment Investigational in Vitro Clinical Test 
                Exemptions'';
                    (B) in paragraph (3)(A), by striking ``or 
                investigational device exemption in effect under 
                section 520(g)'' and inserting ``, investigational 
                device exemption in effect under section 520(g), or 
                investigational in vitro clinical test exemption under 
                section 587R'';
                    (C) by striking ``or treatment investigational 
                device exemption'' each place it appears and inserting 
                ``, treatment investigational device exemption, or 
                treatment investigational in vitro clinical test 
                exemption''; and
                    (D) in the matter following paragraph (7) by 
                striking ``or 520(g)'' each place it appears and 
                inserting ``, 520(g) or 587R''; and
            (4) by amending subsection (e) to read as follows:
    ``(e) Definitions.--In this section, the terms `investigational 
drug', `investigational device', `investigational in vitro clinical 
test', `treatment investigational new drug application', `treatment 
investigational device exemption', and `treatment investigational in 
vitro clinical test exemption' shall have the meanings given the terms 
in regulations prescribed by the Secretary.''.
    (g) Optimizing Global Clinical Trials.--Section 569A(b) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb-8a(b)) is 
amended by inserting ``an in vitro clinical test, as defined in 
subsection (ss) of such section,'' before ``or a biological product''.
    (h) Patient Participation in Medical Product Discussion.--The 
heading of subsection (a) of section 569C of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 360bbb-8c) is amended by striking ``Drugs 
and Devices'' and inserting ``Drugs, Devices, and In Vitro Clinical 
Tests''.
    (i) Regulations and Hearings.--Section 701(h)(1)(C)(ii) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 371(h)(1)(C)(ii)) is 
amended by inserting ``and in vitro clinical tests'' after ``devices''.
    (j) Factory Inspection.--Section 704 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 374) (other than subsection (g)) is amended--
            (1) by striking ``drugs or devices'' each place it appears 
        and inserting ``drugs, devices, or in vitro clinical tests'';
            (2) in subsection (a)(1), in the third sentence, by 
        striking ``or chapter IX'' and inserting ``section 587R or 
        chapter IX'';
            (3) in subsection (a)(2)(B)--
                    (A) by inserting ``or in vitro clinical tests'' 
                after ``prescribe or use devices''; and
                    (B) by inserting ``or in vitro clinical tests'' 
                after ``process devices'';
            (4) by inserting ``in vitro clinical test,'' after 
        ``device,'' each place it appears;
            (5) after making the amendments in paragraphs (1) and (2), 
        by inserting ``in vitro clinical tests,'' after ``devices,'' 
        each place it appears;
            (6) in subsection (e), by inserting ``, or section 587L, 
        587M, or 587R,'' after ``section 519 or 520(g)''; and
            (7) in subsection (f)(3)--
                    (A) in subparagraph (A), by striking ``or'' at the 
                end;
                    (B) in subparagraph (B), by striking the period at 
                the end and inserting ``; or''; and
                    (C) after subparagraph (B), by inserting the 
                following:
            ``(C) is accredited under section 587P.''.
    (k) Publicity.--Section 705(b) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 375(b)) is amended by inserting ``in vitro 
clinical tests,'' after ``devices,''.
    (l) Presumption.--Section 709 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 379a) is amended by inserting ``in vitro 
clinical test,'' after ``device,''.
    (m) Imports and Exports.--Section 801 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 381) is amended--
            (1) in subsection (a)--
                    (A) by inserting ``in vitro clinical tests,'' after 
                ``devices,'' each place it appears; and
                    (B) by inserting ``in the case of an in vitro 
                clinical test, the test does not conform to the 
                applicable requirements of section 587J, or'' after 
                ``requirements of section 520(f), or'';
            (2) in subsection (d)(3)--
                    (A) in subparagraph (A)--
                            (i) in the matter preceding clause (i), by 
                        inserting ``and no component of an in vitro 
                        clinical test or other article of in vitro 
                        clinical test that requires further 
                        processing,'' after ``health-related 
                        purposes'';
                            (ii) in clause (i), by striking ``drug or 
                        device'' and inserting ``drug, device, or in 
                        vitro clinical test''; and
                            (iii) in clause (i)(I), by inserting ``in 
                        vitro clinical test,'' after ``device,''; and
                    (B) in subparagraph (B), by inserting ``in vitro 
                clinical test,'' after ``device,''; and
            (3) in subsection (e)(1), by inserting ``in vitro clinical 
        test,'' after ``device,''.
    (n) Office of International Relations.--Section 803 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 383) is amended--
            (1) in subsection (b)--
                    (A) in the matter preceding paragraph (1), by 
                inserting ``and in vitro clinical tests'' after 
                ``devices''; and
                    (B) in paragraph (1), by inserting ``quality 
                requirements established under section 587J; and'' at 
                the end; and
            (2) in subsection (c)--
                    (A) in paragraph (2), by inserting ``in vitro 
                clinical tests,'' after ``devices,''; and
                    (B) in paragraph (4), by inserting ``or in vitro 
                clinical tests'' after ``devices''.
    (o) Recognition of Foreign Government Inspections.--Section 
809(a)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
384e(a)(1)) is amended by inserting ``, or section 587I'' after 
``510(h)''.
    (p) Food and Drug Administration.--Section 1003(b)(2) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 393(b)(2)) is amended--
            (1) in subparagraph (D), by striking ``and'' at the end;
            (2) in subparagraph (E), by striking the semicolon at the 
        end and inserting ``; and''; and
            (3) by adding at the end the following:
                    ``(F) in vitro clinical tests are analytically and 
                clinically valid;''.
    (q) Office of Women's Health.--Section 1011(b) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 399b(b)) is amended--
            (1) in paragraph (1), by inserting ``in vitro clinical 
        tests,'' after ``devices,''; and
            (2) in paragraph (4), by striking ``and device 
        manufacturers'' and inserting ``device manufacturers, and in 
        vitro clinical test developers,''.
    (r) Countermeasure Provisions of the PHSA.--Title III of the PHSA 
is amended--
            (1) in section 319F-2(c)(1)(B) (42 U.S.C. 247d-6b(c)(1)(B)) 
        is amended--
                    (A) by striking ``or device'' and inserting 
                ``device''; and
                    (B) by inserting ``or an in vitro clinical test (as 
                that term is defined in section 201(ss) of the Federal 
                Food, Drug, and Cosmetic Act (21 U.S.C. 321(ss)))'' 
                after ``Act (21 U.S.C. 321(h)))'';
            (2) in section 319F-1(a)(2) (42 U.S.C. 247d-6a(a)(2)), by 
        inserting ``an in vitro clinical tests (as that term is defined 
        in section 201(ss) of the Federal Food, Drug, and Cosmetic Act 
        (21 U.S.C. 321(ss))),'' before ``or device''; and
            (3) in section 319F-3(i)(7) (42 U.S.C. 247d-6d(i)(7)), by 
        inserting ``an in vitro clinical tests (as that term is defined 
        in section 201(ss) of the Federal Food, Drug, and Cosmetic Act 
        (21 U.S.C. 321(ss))),'' before ``or device''.

SEC. 5. TRANSITION.

    (a) Implementation.--
            (1) Effective date.--
                    (A) In general.--Except as otherwise provided in 
                this section, the amendments made by this Act apply 4 
                years after the date of enactment of this Act (in this 
                section and in subchapter J of chapter V of the Federal 
                Food, Drug, and Cosmetic Act, as added by this Act, 
                referred to in this section as the ``effective date of 
                this Act'').
                    (B) Exception.--The Secretary of Health and Human 
                Services (in this section referred to as the 
                ``Secretary'') may take the actions described in 
                paragraph (2), and may expend such funds as the 
                Secretary determines necessary to ensure an orderly 
                transition.
            (2) Actions.--The Secretary shall, prior to the date on 
        which the amendments made by this Act generally apply pursuant 
        to paragraph (1)--
                    (A) within 1 year of the date of enactment of this 
                Act hold the public meetings described in subchapter J 
                of chapter V of the Federal Food, Drug, and Cosmetic 
                Act, as added by section 3;
                    (B) within 2 years of the date of enactment of this 
                Act promulgate final regulations required under 
                sections 587B, 587D, 587L, 587M, 587V, and 587W; and
                    (C) within 2 years of the date of enactment of this 
                Act issue final guidance on applicability requirements 
                under section 587A.
            (3) Applicability of regulations.--Notwithstanding the date 
        on which guidance or regulations are issued under paragraph 
        (2), no guidance or regulations issued pursuant to the 
        amendments made by this Act shall take effect until the 
        effective date of this Act, as described in paragraph (1), 
        except as otherwise provided for transitional tests under this 
        section.
    (b) Application of Authorities to In Vitro Clinical Tests Until and 
After Effective Date of This Act.--Except as provided in subsections 
(c) and (d), for any in vitro clinical test as defined in section 
201(ss) of the Federal Food, Drug, and Cosmetic Act, as added by this 
Act, the following authorities shall apply:
            (1) Tests offered prior to enactment.--An in vitro clinical 
        test that meets the criteria for a grandfathered test as set 
        forth in section 587A(c)(2) of the Federal Food, Drug, and 
        Cosmetic Act, as added by section 3, may continue to be offered 
        for clinical use and shall be subject only to applicable 
        provisions of section 353 of the Public Health Service Act and 
        section 587A(a)(4) of the Federal Food, Drug, and Cosmetic Act, 
        as added by section 3.
            (2) Tests approved or cleared on or after the date of 
        enactment but prior to the effective date.--Before any in vitro 
        clinical test as defined in section 201(ss) of the Federal 
        Food, Drug, and Cosmetic Act, as added by this Act, is first 
        offered, sold, or distributed after the date of enactment of 
        this Act, but prior to the effective date of this Act, such 
        product or test shall be considered a transitional test as 
        described under subsection (c) and comply with the applicable 
        device provisions of the Federal Food, Drug, and Cosmetic Act 
        (21 U.S.C. 301 et seq.) and the Public Health Service Act (42 
        U.S.C. 201 et seq.).
            (3) Tests under fda review beginning on or after the date 
        of enactment of this act but prior to implementation.--For any 
        in vitro clinical test as defined in section 201(ss) of the 
        Federal Food, Drug, and Cosmetic Act, as added by this Act, for 
        which a submission for marketing authorization under section 
        515, clearance under section 510(k), authorization under 
        section 513(f)(2), approval under section 520(m), or emergency 
        use authorization under section 564 of the Federal Food, Drug, 
        and Cosmetic Act (21 U.S.C. 360e, 360(k), 360c(f)(2), 360j(m), 
        360bbb-3) or approval under the Public Health Service Act (42 
        U.S.C. 201 et seq.) is pending on the effective date of this 
        Act, the Secretary may review and take action on such 
        submission after the effective date of this Act according to 
        the statutory provision under which such submission was 
        submitted.
    (c) Application of Authorities to Transitional and Grandfathered In 
Vitro Clinical Tests.--
            (1) Definition.--For purposes of this section, the term 
        ``transitional in vitro clinical test'' means an in vitro 
        clinical test, as defined in section 201(ss) of the Federal 
        Food, Drug, and Cosmetic Act, as added by this Act, that--
                    (A) is offered for clinical use during the period 
                beginning on the date of enactment of this Act and 
                ending on the date that is 90 days after the effective 
                date of this Act;
                    (B) is developed by a clinical laboratory certified 
                by the Secretary under section 353 of the Public Health 
                Service Act (42 U.S.C. 263a) that meets the 
                requirements for performing high-complexity testing for 
                use only within that certified laboratory or another 
                laboratory within the organization under common 
                ownership; and
                    (C) is not approved under section 515, cleared 
                under section 510(k), authorized under section 
                513(f)(2), subject to an exemption under section 
                520(m), or authorized under section 564 of the Federal 
                Food, Drug, and Cosmetic Act (21 U.S.C. 360e, 360(k), 
                360c(f)(2), 360j(m), 360bbb-3) or approval under the 
                Public Health Service Act (42 U.S.C. 201 et seq.).
            (2) Premarket review or technology certification.--A 
        transitional in vitro clinical test that is the subject of an 
        application for premarket review under section 587B of the 
        Federal Food, Drug, and Cosmetic Act or technology 
        certification application under section 587D of such Act, as 
        added by this Act, that is submitted prior to the effective 
        date of this Act may continue to be offered, sold, or 
        distributed until completion of the Secretary's review of the 
        premarket application or technology certification application.
    (d) Conversion.--
            (1) Deemed premarket approval.--Any in vitro clinical test 
        (as defined in section 201(ss) of the Federal Food, Drug, and 
        Cosmetic Act, as added by this Act) with a premarket approval 
        under section 515, a clearance under section 510(k), an 
        authorization under section 513(f), or a licensure under 
        section 351 of the Public Health Service Act (42 U.S.C. 262) is 
        deemed to have an approved application under section 587B of 
        the Federal Food, Drug, and Cosmetic Act, as added by this Act, 
        beginning on the later of--
                    (A) the effective date of this Act; or
                    (B) such other date, not later than 3 years after 
                such effective date, as the person responsible for the 
                device selects.
            (2) Deemed investigational use approval.--Any in vitro 
        clinical test (as defined in section 201(ss) of the Federal 
        Food, Drug, and Cosmetic Act, as added by this Act) that has an 
        approved investigational device exemption under section 520(g) 
        of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j(g)) 
        is deemed to have an approved investigational use under section 
        587Q of such Act, as added by this Act, beginning on the 
        effective date of this Act.
    (e) Instruments.--An instrument (as defined in section 587 of the 
Federal Food, Drug, and Cosmetic Act, as added by this Act) that was 
purchased prior to the date of enactment of this Act and was not 
cleared, authorized, or approved by the Food and Drug Administration or 
part of an instrument family that was cleared, authorized, or approved 
by the Food and Drug Administration at the time of purchase may 
continue to be used by the purchaser to develop and introduce into 
interstate commerce an in vitro clinical test during the period 
beginning on the date of enactment of this Act and ending 5 years after 
such date of enactment. Beginning at the end of such period, any new in 
vitro clinical test that is developed and introduced into interstate 
commerce shall be based on an instrument (as defined in section 587(11) 
of the Federal Food, Drug, and Cosmetic Act, as added by section 3) 
that complies with the requirements of the Federal Food, Drug, and 
Cosmetic Act, as amended by this Act.
    (f) Relation to In Vitro Clinical Test Provision.--This section 
applies notwithstanding section 587A(a)(1)(C) of the Federal Food, 
Drug, and Cosmetic Act, as added by this Act.

SEC. 6. EMERGENCY USE AUTHORIZATION.

    Section 564 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360bbb-3) is amended--
            (1) in paragraphs (1) and (4)(C) of subsection (a), by 
        inserting ``in vitro clinical test,'' before ``or biological 
        product'' each place such term appears; and
            (2) in subsection (e)(3)--
                    (A) in subparagraph (B), by striking ``and'' at the 
                end;
                    (B) in subparagraph (C), by striking the period and 
                inserting ``; and''; and
                    (C) by adding at the end the following:
                    ``(D) quality system requirements (with respect to 
                in vitro clinical tests) under section 587J.''.

SEC. 7. ANTIMICROBIAL SUSCEPTIBILITY TESTS.

    Section 511A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360a-2) is amended--
            (1) in subsection (a)(1)(C)--
                    (A) by striking ``or approve under section 515'' 
                and inserting ``approve under section 515, or approve, 
                exempt, or issue a technology certification order under 
                subchapter J''; and
                    (B) by striking ``testing devices'' and inserting 
                ``tests'';
            (2) in subsection (c)(5), by striking ``drug or device'' 
        each place it appears and inserting ``drug, device, or in vitro 
        clinical test'';
            (3) in subsection (e)--
                    (A) in the heading, by striking ``Testing Devices'' 
                and inserting ``In Vitro Clinical Tests'';
                    (B) in paragraph (1)--
                            (i) by striking ``and 515,'' and inserting 
                        ``515, 587B, and 587D'';
                            (ii) by striking ``antimicrobial 
                        susceptibility testing device'' and inserting 
                        ``antimicrobial susceptibility in vitro 
                        clinical test''; and
                            (iii) by striking ``such device'' and 
                        inserting ``such test'';
                    (C) in paragraph (2)--
                            (i) in the heading, by striking ``testing 
                        devices'' and inserting ``in vitro clinical 
                        tests''; and
                            (ii) by amending subparagraph (C) to read 
                        as follows:
                    ``(C) The antimicrobial susceptibility in vitro 
                clinical test meets all other requirements to be 
                approved under section 587B or exempted from premarket 
                review under section 587D.''; and
                    (D) after making the amendments in subparagraphs 
                (B)(ii), (B)(iii), and (C)(ii), by striking ``device'' 
                each place it appears and inserting ``in vitro clinical 
                test'';
            (4) in subsection (f), by amending paragraph (1) to read as 
        follows:
            ``(1) The term `antimicrobial susceptibility in vitro 
        clinical test' means an in vitro clinical test that utilizes 
        susceptibility test interpretive criteria to determine and 
        report the in vitro susceptibility of certain microorganisms to 
        a drug (or drugs).''; and
            (5) in subsection (g)(2)--
                    (A) by amending the matter preceding subparagraph 
                (A) to read as follows:
            ``(2) with respect to clearing under section 510(k), 
        classifying under section 513(f)(2), approving under section 
        515 or section 587B, or exempting from approval requirements 
        under section 587D--''; and
                    (B) in subparagraph (A)--
                            (i) by striking ``device'' and inserting 
                        ``in vitro clinical test''; and
                            (ii) by striking ``antimicrobial 
                        susceptibility testing device'' and inserting 
                        ``antimicrobial susceptibility in vitro 
                        clinical test''.

SEC. 8. COMBINATION PRODUCTS.

    (a) In General.--Section 503(g) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 353(g)) is amended--
            (1) in paragraph (1)--
                    (A) in subparagraph (A)--
                            (i) by inserting ``(except for a 
                        combination product constituted of a device and 
                        an in vitro clinical test)'' after ``agency 
                        center,''; and
                            (ii) by inserting ``in vitro clinical 
                        test,'' before ``or biological product''; and
                    (B) in subparagraph (D)--
                            (i) in the matter preceding clause (i), by 
                        striking ``. If the Secretary determines'' and 
                        inserting ``, except for a combination product 
                        constituted of a device and an in vitro 
                        clinical test. For other combination products, 
                        if the Secretary determines''; and
                            (ii) in clause (ii)--
                                    (I) by inserting ``or in vitro 
                                clinical test'' after ``device''; and
                                    (II) by inserting ``and in vitro 
                                clinical tests'' before ``shall'';
            (2) in paragraph (3), by striking ``safety and 
        effectiveness or substantial equivalence'' and inserting 
        ``safety and effectiveness, substantial equivalence, or 
        analytical validity and clinical validity'' before ``for the 
        approved constituent part'';
            (3) in paragraph (4)--
                    (A) in subparagraph (A), by striking ``or 513(f)(2) 
                (submitted in accordance with paragraph (5))'' and 
                inserting ``513(f)(2) (submitted in accordance with 
                paragraph (5)), 587B, or an exempt test under section 
                587A, as applicable''; and
                    (B) in subparagraph (B), by inserting ``or 587B'' 
                after ``section 515'';
            (4) in paragraph (5)(A), by striking ``or 510(k)'' and 
        inserting ``, 510(k), or 587B'';
            (5) in paragraph (7), by striking ``or substantial 
        equivalence'' and inserting ``, substantial equivalence, or 
        analytical validity and clinical validity'';
            (6) in paragraph (8), by adding at the end the following:
                    ``(I) This paragraph shall not apply to a 
                combination product constituted of a device and an in 
                vitro clinical test.''; and
            (7) in paragraph (9)--
                    (A) in subparagraph (C)(i), by striking ``or 
                520(g)'' and inserting ``520(g), or 587B''; and
                    (B) in subparagraph (D), by striking ``or 520'' and 
                inserting ``520, or 587B''.
    (b) Classification of Products.--Section 563 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 360bbb-2) is amended by adding at the 
end the following:
    ``(d) Exemption.--This section shall not apply to a combination 
product constituted of a device and an in vitro clinical test.''.

SEC. 9. RESOURCES.

    (a) Findings.--Congress finds that the fees authorized by this 
section will be dedicated to meeting the goals identified in the 
letters from the Secretary of Health and Human Services to the 
Committee on Health, Education, Labor, and Pensions of the Senate and 
the Committee on Energy and Commerce of the House of Representatives, 
as set forth in the Congressional Record.
    (b) Establishment of User Fee Program.--
            (1) Development of user fees for in vitro clinical tests.--
                    (A) In general.--Beginning not later than October 
                1, 2021, the Secretary of Health and Human Services (in 
                this section referred to as the ``Secretary'') shall 
                develop recommendations to present to Congress with 
                respect to the goals, and plans for meeting the goals, 
                for the process of the review of in vitro clinical test 
                applications submitted under subchapter J of chapter V 
                of the Federal Food, Drug, and Cosmetic Act, as added 
                by this Act, for the first 5 fiscal years after fiscal 
                year 2022. In developing such recommendations, the 
                Secretary shall consult with--
                            (i) the Committee on Energy and Commerce of 
                        the House of Representatives;
                            (ii) the Committee on Health, Education, 
                        Labor, and Pensions of the Senate;
                            (iii) scientific and academic experts;
                            (iv) health care professionals;
                            (v) representatives of patient and consumer 
                        advocacy groups; and
                            (vi) the regulated industry.
                    (B) Prior public input.--Prior to beginning 
                negotiations with the regulated industry on the 
                authorization of such subchapter J, the Secretary 
                shall--
                            (i) publish a notice in the Federal 
                        Register requesting public input on the 
                        authorization of user fees;
                            (ii) hold a public meeting at which the 
                        public may present its views on the 
                        authorization, including specific suggestions 
                        for the recommendations submitted under 
                        subparagraph (E);
                            (iii) provide a period of 30 days after the 
                        public meeting to obtain written comments from 
                        the public suggesting changes to such 
                        subchapter J; and
                            (iv) publish any comments received under 
                        clause (iii) on the website of the Food and 
                        Drug Administration.
                    (C) Periodic consultation.--Not less frequently 
                than once every month during negotiations with the 
                regulated industry, the Secretary shall hold 
                discussions with representatives of patient and 
                consumer advocacy groups to continue discussions of the 
                authorization under such subchapter J and to solicit 
                suggestions to be included in the recommendations 
                transmitted to Congress under subparagraph (E).
                    (D) Public review of recommendations.--After 
                negotiations with the regulated industry, the Secretary 
                shall--
                            (i) present the recommendations developed 
                        under subparagraph (A) to the Committee on 
                        Health, Education, Labor, and Pensions of the 
                        Senate and the Committee on Energy and Commerce 
                        of the House of Representatives;
                            (ii) publish such recommendations in the 
                        Federal Register;
                            (iii) provide for a period of 30 days for 
                        the public to provide written comments on such 
                        recommendations;
                            (iv) hold a meeting at which the public may 
                        present its views on such recommendations; and
                            (v) after consideration of such public 
                        views and comments, revise such recommendations 
                        as necessary.
                    (E) Transmittal of recommendations.--
                            (i) In general.--Not later than June 1, 
                        2021, the Secretary shall transmit to Congress 
                        the revised recommendations under subparagraph 
                        (A), a summary of the views and comments 
                        received under such subparagraph, and any 
                        changes made to the recommendations in response 
                        to such views and comments.
                            (ii) Recommendation requirements.--The 
                        recommendations transmitted under this 
                        subparagraph shall--
                                    (I) include the number of full-time 
                                equivalent employees per fiscal year 
                                that are agreed to be hired to carry 
                                out the goals included in such 
                                recommendations for each year of the 5-
                                year period;
                                    (II) provide that the amount of 
                                operating reserve balance in the user 
                                fee program established under this 
                                section is not more than the equivalent 
                                of 10 weeks of operating reserve;
                                    (III) require the development of a 
                                strategic plan for any surplus within 
                                the operating reserve account above the 
                                10-week operating reserve within 2 
                                years of the establishment of the 
                                program;
                                    (IV) include an operating reserve 
                                adjustment such that, if the Secretary 
                                has an operating reserve balance in 
                                excess of 10 weeks of such operating 
                                reserves, the Secretary shall decrease 
                                such fee revenue and fees to provide 
                                for not more than 10 weeks of such 
                                operating reserves;
                                    (V) if an adjustment is made as 
                                described in subclause (IV), provide 
                                the rationale for the amount of the 
                                decrease in fee revenue and fees shall 
                                be contained in the Federal Register; 
                                and
                                    (VI) provide that the fees assessed 
                                and collected for the full-time 
                                equivalent employees at the Center for 
                                Devices and Radiological Health, with 
                                respect to which the majority of time 
                                reporting data indicates are dedicated 
                                to the review of in vitro clinical 
                                tests, are not supported by the funds 
                                authorized to be collected and assessed 
                                under section 738 of the Federal Food, 
                                Drug, and Cosmetic Act (21 U.S.C. 
                                379j).
                    (F) Publication of recommendations.--The Secretary 
                shall publish on the website of the Food and Drug 
                Administration the revised recommendations under 
                subparagraph (A), a summary of the views and comments 
                received under subparagraphs (B) through (D), and any 
                changes made to the recommendations originally proposed 
                by the Secretary in response to such views and 
                comments.
                    (G) Minutes of negotiation meetings.--
                            (i) Public availability.--Before 
                        transmitting the recommendations developed 
                        under subparagraphs (A) through (F) to 
                        Congress, the Secretary shall make publicly 
                        available, on the website of the Food and Drug 
                        Administration, minutes of all negotiation 
                        meetings conducted under this subsection 
                        between the Food and Drug Administration and 
                        the regulated industry.
                            (ii) Content.--The minutes described under 
                        clause (i) shall summarize any substantive 
                        proposal made by any party to the negotiations, 
                        any significant controversies or differences of 
                        opinion during the negotiations, and the 
                        resolution of any such controversy or 
                        difference of opinion.
            (2) Establishment of user fee program.--Effective on 
        October 1, 2021, provided that the Secretary transmits the 
        recommendations under paragraph (1)(E), the Secretary is 
        authorized to collect user fees relating to the submission of 
        in vitro clinical test applications submitted under subchapter 
        J of chapter V of the Federal Food, Drug, and Cosmetic Act, as 
        added by this Act. Fees under such program shall be assessed 
        and collected only if the requirements under paragraph (4) are 
        met.
            (3) Audit.--
                    (A) In general.--On the date that is 2 years after 
                first receiving a user fee applicable to submission of 
                an in vitro clinical test application submitted under 
                subchapter J of chapter V of the Federal Food, Drug, 
                and Cosmetic Act, as added by this Act, and on a 
                biennial basis thereafter until October 1, 2027, the 
                Secretary shall perform an audit of the costs of 
                reviewing such applications under such subchapter J. 
                Such an audit shall compare the costs of reviewing such 
                applications under such subchapter J to the amount of 
                the user fee applicable to such applications.
                    (B) Alteration of user fee.--If the audit performed 
                under subparagraph (A) indicates that the user fees 
                applicable to applications submitted under such 
                subchapter J exceed 30 percent of the costs of 
                reviewing such applications, the Secretary shall alter 
                the user fees applicable to applications submitted 
                under such subchapter J such that the user fees do not 
                exceed such percentage.
                    (C) Accounting standards.--The Secretary shall 
                perform an audit under subparagraph (A) in conformance 
                with the accounting principles, standards, and 
                requirements prescribed by the Comptroller General of 
                the United States under section 3511 of title 31, 
                United States Code, to ensure the validity of any 
                potential variability.
            (4) Conditions.--The user fee program described in this 
        subsection shall take effect only if the Food and Drug 
        Administration issues draft guidance related to the review 
        requirements for in vitro diagnostic tests that would be 
        subject to premarket review under section 587B of the Federal 
        Food, Drug, and Cosmetic Act, as added by section 3, the review 
        requirements for test categories eligible for technology 
        certification under section 587D of such Act, as added by 
        section 3, and the parameters for the test categories that 
        would be exempt from any review under subchapter J of chapter V 
        of such Act.
            (5) User fee program definitions and resource 
        requirements.--
                    (A) In general.--The term ``process for the review 
                of in vitro clinical test applications'' means the 
                following activities of the Secretary with respect to 
                the review of premarket applications under section 587B 
                of the Federal Food, Drug, and Cosmetic Act (as added 
                by section 3), technology certification applications 
                under section 587D of such Act (as added by section 3), 
                and supplements for such applications:
                            (i) The activities necessary for the review 
                        of premarket applications, premarket reports, 
                        and supplements to such applications.
                            (ii) The issuance of action letters that 
                        allow the marketing of in vitro clinical tests 
                        or which set forth in detail the specific 
                        deficiencies in such applications, reports, 
                        supplements, or submissions and, where 
                        appropriate, the actions necessary to place 
                        them in condition for approval.
                            (iii) The inspection of manufacturing 
                        establishments and other facilities undertaken 
                        as part of the Secretary's review of pending 
                        premarket applications, technology 
                        certifications, and supplements.
                            (iv) Monitoring of research conducted in 
                        connection with the review of such 
                        applications, supplements, and submissions.
                            (v) Review of in vitro clinical test 
                        applications subject to section 351 of the 
                        Public Health Service Act (42 U.S.C. 262), 
                        investigational new drug applications under 
                        section 505(i) of the Federal Food, Drug, and 
                        Cosmetic Act (21 U.S.C. 355(i)), or 
                        investigational test exemptions under section 
                        587A(m) of the Federal Food, Drug, and Cosmetic 
                        Act (as added by section 3), and activities 
                        conducted in anticipation of the submission of 
                        such applications under section 505(i) of the 
                        Federal Food, Drug, and Cosmetic Act or 
                        investigational use under section 587R of the 
                        Federal Food, Drug, and Cosmetic Act (as added 
                        by section 3).
                            (vi) The development of guidance, policy 
                        documents, or regulations to improve the 
                        process for the review of premarket 
                        applications, technology certification 
                        applications, and supplements.
                            (vii) The development of voluntary test 
                        methods, consensus standards, or mandatory 
                        performance standards in connection with the 
                        review of such applications, supplements, or 
                        submissions and related activities.
                            (viii) The provision of technical 
                        assistance to in vitro clinical test developers 
                        in connection with the submission of such 
                        applications, reports, supplements, or 
                        submissions.
                            (ix) Any activity undertaken in connection 
                        with the initial classification or 
                        reclassification of an in vitro clinical test 
                        in connection with any requirement for approval 
                        of an in vitro clinical test.
                            (x) Evaluation of postmarket studies 
                        required as a condition of an approval of a 
                        premarket application of an in vitro clinical 
                        test.
                            (xi) Compiling, developing, and reviewing 
                        information on relevant in vitro clinical tests 
                        to identify issues with the applicable standard 
                        for premarket applications, technology 
                        certification applications, and supplements.
                    (B) Resource requirements.--Fees collected and 
                assessed under this section shall be used for the 
                process for the review of in vitro clinical test 
                applications, as described in subparagraph (A), and 
                shall--
                            (i) be subject to the limitation under 
                        section 738(g)(3) of the Federal Food, Drug, 
                        and Cosmetic Act (21 U.S.C. 379j(g)(3)), in the 
                        same manner that fees collected and assessed 
                        under section 737(9)(C) of such Act (21 U.S.C. 
                        379i(9)(C)) are subject to such limitation;
                            (ii) include travel expenses for officers 
                        and employees of the Food and Drug 
                        Administration only if the Secretary determines 
                        that such travel is directly related to an 
                        activity described in subparagraph (A); and
                            (iii) not be allocated to purposes 
                        described under section 722(a) of the 
                        Consolidated Appropriations Act, 2018 (Public 
                        Law 115-141).
    (c) Reports.--
            (1) Performance report.--
                    (A) In general.--
                            (i) General requirements.--Beginning with 
                        fiscal year 2021, for each fiscal year for 
                        which fees are collected under this section, 
                        the Secretary shall prepare and submit to the 
                        Committee on Health, Education, Labor, and 
                        Pensions of the Senate and the Committee on 
                        Energy and Commerce of the House of 
                        Representatives annual reports concerning the 
                        progress of the Food and Drug Administration in 
                        achieving the goals identified in the 
                        recommendations transmitted to Congress by the 
                        Secretary pursuant to subsection (b)(1)(E) 
                        during such fiscal year and the future plans of 
                        the Food and Drug Administration for meeting 
                        the goals.
                            (ii) Additional information.--Beginning 
                        with fiscal year 2021, the annual report under 
                        this subparagraph shall include the progress of 
                        the Food and Drug Administration in achieving 
                        the goals, and future plans for meeting the 
                        goals, including--
                                    (I) the number of premarket 
                                applications filed under section 587B 
                                of the Federal Food, Drug, and Cosmetic 
                                Act during the applicable fiscal year;
                                    (II) the number of technology 
                                certification applications submitted 
                                under section 587D of the Federal Food, 
                                Drug, and Cosmetic Act during the 
                                applicable fiscal year for each review 
                                division; and
                                    (III) the number of breakthrough 
                                designations under section 587C of the 
                                Federal Food, Drug, and Cosmetic Act 
                                during the applicable fiscal year.
                            (iii) Real-time reporting.--
                                    (I) In general.--Not later than 30 
                                calendar days after the end of the 
                                second quarter of fiscal year 2021, and 
                                not later than 30 calendar days after 
                                the end of each quarter of each fiscal 
                                year thereafter, the Secretary shall 
                                post the data described in subclause 
                                (II) on the website of the Food and 
                                Drug Administration for such quarter 
                                and on a cumulative basis for such 
                                fiscal year, and may remove duplicative 
                                data from the annual report under this 
                                subparagraph.
                                    (II) Data.--The Secretary shall 
                                post the following data in accordance 
                                with subclause (I):
                                            (aa) The number and titles 
                                        of draft and final guidance on 
                                        topics related to the process 
                                        for the review of in vitro 
                                        clinical tests, and whether 
                                        such guidances were issued as 
                                        required by statute or pursuant 
                                        to the recommendations 
                                        transmitted to Congress by the 
                                        Secretary pursuant to 
                                        subsection (b)(1)(E).
                                            (bb) The number and titles 
                                        of public meetings held on 
                                        topics related to the process 
                                        for the review of in vitro 
                                        clinical tests, and if such 
                                        meetings were required by 
                                        statute or pursuant to the 
                                        recommendations transmitted to 
                                        Congress by the Secretary 
                                        pursuant to subsection 
                                        (b)(1)(E).
                            (iv) Rationale for ivct user fee program 
                        changes.--Beginning with fiscal year 2022, the 
                        Secretary shall include in the annual 
                        performance report under paragraph (1)--
                                    (I) data, analysis, and discussion 
                                of the changes in the number of full-
                                time equivalents hired as agreed upon 
                                in the recommendations transmitted to 
                                Congress by the Secretary pursuant to 
                                subsection (b)(1)(E) and the number of 
                                full-time equivalents funded by budget 
                                authority at the Food and Drug 
                                Administration by each division within 
                                the Center for Devices and Radiological 
                                Health, the Center for Biologics 
                                Evaluation and Research, the Office of 
                                Regulatory Affairs, and the Office of 
                                the Commissioner;
                                    (II) data, analysis, and discussion 
                                of the changes in the fee revenue 
                                amounts and costs for the process for 
                                the review of in vitro clinical tests, 
                                including identifying drivers of such 
                                changes; and
                                    (III) for each of the Center for 
                                Devices and Radiological Health, the 
                                Center for Biologics Evaluation and 
                                Research, the Office of Regulatory 
                                Affairs, and the Office of the 
                                Commissioner, the number of employees 
                                for whom time reporting is required and 
                                the number of employees for whom time 
                                reporting is not required.
                            (v) Analysis.--For each fiscal year, the 
                        Secretary shall include in the report under 
                        clause (i) an analysis of the following:
                                    (I) The difference between the 
                                aggregate number of premarket 
                                applications filed under section 587B 
                                or section 587D of the Federal Food, 
                                Drug, and Cosmetic Act and the 
                                aggregate number of major deficiency 
                                letters, not approvable letters, and 
                                denials for such applications issued by 
                                the agency, accounting for--
                                            (aa) the number of 
                                        applications filed under each 
                                        of sections 587B and 587D of 
                                        the Federal Food, Drug, and 
                                        Cosmetic Act during one fiscal 
                                        year for which a decision is 
                                        not scheduled to be made until 
                                        the following fiscal year; and
                                            (bb) the aggregate number 
                                        of applications under each of 
                                        sections 587B and 587D of the 
                                        Federal Food, Drug, and 
                                        Cosmetic Act for each fiscal 
                                        year that did not meet the 
                                        goals as identified by the 
                                        recommendations transmitted to 
                                        Congress by the Secretary 
                                        pursuant to subsection 
                                        (b)(1)(E).
                                    (II) Relevant data to determine 
                                whether the Center for Devices and 
                                Radiological Health has met performance 
                                enhancement goals identified by the 
                                recommendations transmitted to Congress 
                                by the Secretary pursuant to subsection 
                                (b)(1)(E).
                                    (III) The most common causes and 
                                trends for external or other 
                                circumstances affecting the ability of 
                                the Food and Drug Administration to 
                                meet review time and performance 
                                enhancement goals identified by the 
                                recommendations transmitted to Congress 
                                by the Secretary pursuant to subsection 
                                (b)(1)(E).
                    (B) Publication.--With regard to information to be 
                reported by the Food and Drug Administration to 
                industry on a quarterly and annual basis pursuant to 
                recommendations transmitted to Congress by the 
                Secretary pursuant to subsection (b)(1)(E), the 
                Secretary shall make such information publicly 
                available on the website of the Food and Drug 
                Administration not later than 60 days after the end of 
                each quarter or 120 days after the end of each fiscal 
                year, respectively, to which such information applies.
                    (C) Updates.--The Secretary shall include in each 
                report under subparagraph (A) information on all 
                previous cohorts for which the Secretary has not given 
                a complete response on all in vitro clinical test 
                premarket applications and technology certification 
                orders and supplements, premarket, and technology 
                certification notifications in the cohort.
            (2) Corrective action report.--Beginning with fiscal year 
        2022, for each fiscal year for which fees are collected under 
        this section, the Secretary shall prepare and submit a 
        corrective action report to the Committee on Health, Education, 
        Labor, and Pensions and the Committee on Appropriations of the 
        Senate and the Committee on Energy and Commerce and the 
        Committee on Appropriations of the House of Representatives. 
        The report shall include the following information, as 
        applicable:
                    (A) Goals met.--For each fiscal year, if the 
                Secretary determines, based on the analysis under 
                paragraph (1)(A)(v), that each of the goals identified 
                by the recommendations transmitted to Congress by the 
                Secretary pursuant to subsection (b)(1)(E) for the 
                applicable fiscal year have been met, the corrective 
                action report shall include recommendations on ways in 
                which the Secretary can improve and streamline the in 
                vitro clinical test premarket application and 
                technology certification review process.
                    (B) Goals missed.--For each of the goals identified 
                by the letters described in recommendations transmitted 
                to Congress by the Secretary pursuant to subsection 
                (b)(1)(E) for the applicable fiscal year that the 
                Secretary determines to not have been met, the 
                corrective action report shall include--
                            (i) a justification for such determination;
                            (ii) a description of the types of 
                        circumstances, in the aggregate, under which 
                        applications or reports submitted under 
                        sections 587B and 587D of the Federal Food, 
                        Drug, and Cosmetic Act missed the review goal 
                        times but were approved during the first cycle 
                        review, as applicable;
                            (iii) a summary and any trends with regard 
                        to the circumstances for which a review goal 
                        was missed; and
                            (iv) the performance enhancement goals that 
                        were not achieved during the previous fiscal 
                        year and a description of efforts the Food and 
                        Drug Administration has put in place for the 
                        fiscal year in which the report is submitted to 
                        improve the ability of such agency to meet each 
                        such goal for the such fiscal year.
            (3) Fiscal report.--For fiscal years 2021 and annually 
        thereafter, not later than 120 days after the end of each 
        fiscal year during which fees are collected under this subpart, 
        the Secretary shall prepare and submit to the Committee on 
        Health, Education, Labor, and Pensions of the Senate and the 
        Committee on Energy and Commerce of the House of 
        Representatives, a report on the implementation of the 
        authority for such fees during such fiscal year and the use, by 
        the Food and Drug Administration, of the fees collected during 
        such fiscal year for which the report is made.
                    (A) Contents.--Such report shall include 
                expenditures delineated by budget authority and user 
                fee dollars related to administrative expenses and 
                information technology infrastructure contracts and 
                expenditures.
                    (B) Operating reserve.--Such report shall provide 
                the amount of operating reserve balance available each 
                year, and any planned allocations or obligations of 
                such balance that is above 10 weeks of operating 
                reserve for the program.
            (4) Public availability.--The Secretary shall make the 
        reports required under paragraphs (1) through (3) available to 
        the public on the website of the Food and Drug Administration.
            (5) Enhanced communication.--
                    (A) Communications with congress.--Each fiscal 
                year, as applicable and requested, representatives from 
                the Centers with expertise in the review of in vitro 
                clinical tests shall meet with representatives from the 
                Committee on Health, Education, Labor, and Pensions of 
                the Senate and the Committee on Energy and Commerce of 
                the House of Representatives to report on the contents 
                described in the reports under this section.
                    (B) Participation in congressional hearing.--Each 
                fiscal year, as applicable and requested, 
                representatives from the Food and Drug Administration 
                shall participate in a public hearing before the 
                Committee on Health, Education, Labor, and Pensions of 
                the Senate and the Committee on Energy and Commerce of 
                the House of Representatives, to report on the contents 
                described in the reports under this section. Such 
                hearing shall occur not later than 120 days after the 
                end of each fiscal year for which fees are collected 
                under this section.
                                 <all>