I 
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 Representa-
tives 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. 
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‘‘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 
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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 determina-
tion 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 pro-
tocol; 
‘‘(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 compo-
nent or part of a test, a test protocol, an instru-
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ment, an article, or software described in any of 
clauses (A) through (D) of such subparagraph, 
whether alone or in combination, including re-
agents, 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 con-
sists 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 arti-
cle for holding, storing, or transporting a specimen. 
‘‘(C) General purpose laboratory equipment, in-
cluding certain pre-analytical equipment, as deter-
mined by the Secretary. 
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‘‘(D) An article used solely for personal protec-
tion during the administering, conducting, or other-
wise 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 clin-
ical 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 Serv-
ice Act (42 U.S.C. 262(i)(1)) is amended— 
(1) by striking ‘‘(1) The term ‘biological prod-
uct’ means’’ and inserting ‘‘(1)(A) The term ‘biologi-
cal product’ means’’; and 
(2) by adding at the end the following: 
‘‘(B) The term ‘biological product’ does not in-
clude 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). 
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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 fol-
lowing: 
‘‘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 abil-
ity of the in vitro clinical test, to— 
‘‘(i) sufficiently identify, measure, de-
tect, 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 iden-
tification, measurement, detection, calcula-
tion, or analysis. 
‘‘(B) For an article for taking or deriving 
specimens from the human body described in 
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section 201(ss)(1)(B)(iii), the term ‘analytical 
validity’ means that such article performs as in-
tended and will support the analytical validity 
of an in vitro clinical test with which it is used. 
‘‘(2) APPLICABLE STANDARD.—The term ‘ap-
plicable 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 va-
lidity; 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 
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to achieve the purpose for which it is intended as de-
scribed 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 re-
spect 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 ini-
tially developed by a different person in a man-
ner that— 
‘‘(i) changes any of the listing ele-
ments that define indications for use speci-
fied 
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 in-
tended by the developer; or 
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‘‘(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 dif-
fer 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 subpara-
graph (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 in-
tended by the developer, an undetected in-
accurate result from such test or cat-
egory— 
‘‘(I) presents unreasonable risk 
for serious or irreversible harm or 
death to a patient or patients, or 
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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 perform-
ance of the test or tests are well-estab-
lished for the intended use, the clinical cir-
cumstances under which the in vitro clin-
ical test is used, and the availability of 
other tests (such as confirmatory or ad-
junctive tests). 
‘‘(B) EXCEPTION.—The term ‘high-risk’ 
does not include an in vitro clinical test de-
scribed in subparagraph (A) if— 
‘‘(i) mitigating measures are estab-
lished to prevent, detect, or otherwise miti-
gate the risk of inaccurate results as de-
scribed in subparagraph (A), or 
‘‘(ii) an exemption from the definition 
of such term applies under section 587A. 
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‘‘(10) INDICATIONS FOR USE.—The term ‘indi-
cations for use’ means one or more in vitro clinical 
tests that have all of the following notification ele-
ments 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 de-
scribed in section 201(ss)(1)(A). 
‘‘(D) Diseases or conditions for which the 
in vitro clinical test is intended for use, includ-
ing 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 in-
tended by the hardware’s developer to be used with 
one or more in vitro clinical tests to generate a clin-
ical test result, including software used to effectuate 
the hardware’s functionality. 
‘‘(12) INSTRUMENT FAMILY.—The term ‘instru-
ment family’ means more than one instrument for 
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which the developer demonstrates and documents, 
with respect to all such instruments, that all— 
‘‘(A) have the same basic architecture, de-
sign, 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 prin-
ciples, detection methods, and reaction condi-
tions; and 
‘‘(D) produce the same or similar analyt-
ical results from samples of the same specimen 
type or types. 
‘‘(13) LABORATORY
OPERATIONS.—The term 
‘laboratory operations’— 
‘‘(A) means the conduct of a laboratory ex-
amination or other laboratory procedure on ma-
terials derived from the human body, including 
the conduct of an in vitro clinical test and asso-
ciated activities within or under the oversight of 
a laboratory and not related to the design of an 
in vitro clinical test; and 
‘‘(B) includes— 
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‘‘(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 re-
spect to an in vitro clinical test or category of in 
vitro clinical tests, means that an undetected inac-
curate result from such in vitro clinical test, or such 
category of in vitro clinical tests, when used as in-
tended by the developer— 
‘‘(A) would cause minimal or no harm, or 
minimal or no disability, or immediately revers-
ible 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-estab-
lished for the intended use, the clinical cir-
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cumstances under which the in vitro clinical 
test or category of tests is used, and the avail-
ability 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 require-
ments that the Secretary determines, based on 
available evidence— 
‘‘(i) are necessary for an in vitro clin-
ical test, or a category of in vitro clinical 
tests, to meet the applicable standard; or 
‘‘(ii) to mitigate the risk of harm en-
suing from an inaccurate result such that 
a test or category of tests subject to such 
mitigating measures does not meet the def-
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inition 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, perform-
ance testing, submission of clinical data, adver-
tising, website posting of information, clinical 
studies, postmarket surveillance, user com-
prehension 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 de-
scribed 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 dif-
fer in control mechanisms, energy sources, or 
operating principals and for which design, de-
velopment, and manufacturing, including ana-
lytical and clinical validation as applicable, of 
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the tests would be addressed in a similar man-
ner or through similar procedures; and 
‘‘(B) may include clot detection, colori-
metric 
(non-immunoassay), 
electrochemical 
(non-immunoassay), 
enzymatic 
(non- 
immunoassay), flow cytometry, fluorometry 
(non-immunoassay), immunoassay, mass spec-
trometry or chromatography (such as HPLC), 
microbial culture, next generation sequencing 
(also known as ‘NGS’), nephlometric or turbi-
dimetric (non-immunoassay), singleplex or mul-
tiplex non-NGS nucleic acid analysis, single- 
based technology, spectroscopy, and any other 
technology, as the Secretary determines appro-
priate. 
‘‘(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 eval-
uated by persons qualified by training or 
experience to do so, using procedures gen-
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erally accepted by other persons so quali-
fied; 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 in-
tended use; and 
‘‘(B) may include evidence described in 
subparagraph (A) consisting of— 
‘‘(i) peer-reviewed literature; 
‘‘(ii) clinical guidelines; 
‘‘(iii) reports of significant human ex-
perience 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 
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purpose of making a regulatory determina-
tion 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. 
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‘‘(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 enforc-
ing 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 sub-
ject to any provision or requirement of this Act 
other than this subchapter unless such other 
provision or requirement— 
‘‘(i) applies expressly to in vitro clin-
ical 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 CERTIFI-
CATION
PURSUANT
TO
SECTION
353
OF
THE 
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PHSA.—Nothing in this subchapter shall be 
construed to modify the authority of the Sec-
retary with respect to laboratories or clinical 
laboratories under section 353 of the Public 
Health Service Act. 
‘‘(B) AVOIDING DUPLICATION.—In imple-
menting 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 lab-
oratories, 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 sub-
chapter 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 
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within a health care practitioner-patient rela-
tionship pursuant to applicable Federal or State 
law. 
‘‘(B) RULES OF CONSTRUCTION.— 
‘‘(i) SALE, 
DISTRIBUTION, 
LABEL-
ING.—Nothing in this paragraph shall be 
construed to limit the authority of the Sec-
retary 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 pre-
market 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— 
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‘‘(i)(I) there is insufficient valid sci-
entific 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 materi-
ally 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 recep-
tacles, there is sufficient valid scientific 
evidence indicating that a specimen recep-
tacle 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 sub-
paragraph (A) apply to an in vitro clinical 
test, the Secretary may request that the 
developer of the test submit information— 
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‘‘(I) pertaining to such criteria; 
and 
‘‘(II) establishing the basis for 
any claimed exemption from pre-
market review. 
‘‘(ii) DEADLINE FOR SUBMITTING IN-
FORMATION.—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 re-
ceiving a submission under clause (ii), the 
Secretary shall— 
‘‘(I) review the submitted infor-
mation within 60 calendar days of 
such receipt; and 
‘‘(II) determine whether the cri-
teria listed in subparagraph (A) apply 
to the in vitro clinical test. 
‘‘(iv) 
PREMARKET
REVIEW
RE-
QUIRED.— 
‘‘(I) IN
GENERAL.—If the Sec-
retary finds that the criteria listed in 
subparagraph (A) apply to the in vitro 
clinical test, the developer shall— 
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‘‘(aa) promptly, and not 
later than 90 days after the date 
of receipt of such information, 
submit an application for pre-
market review of the test under 
section 587B; or 
‘‘(bb) cease to market the 
test. 
‘‘(II) 
EXTENSION.—The 
Sec-
retary may grant an extension to a 
developer of the 90-day time period 
under subclause (I)(aa), as appro-
priate. 
‘‘(v) CONTINUED
MARKETING.—Dur-
ing 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 con-
tinue 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. 
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‘‘(vi) ORDER
TO
CEASE
DISTRIBU-
TION.— 
‘‘(I) IN GENERAL.—If the devel-
oper of an in vitro clinical test fails to 
submit an application for premarket 
review of the test by the deadline ap-
plicable under clause (iv), or the Sec-
retary 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 Sec-
retary may issue an order, within 10 
calendar days of the applicable dead-
line or finding by the Secretary, re-
quiring the developer of such in vitro 
clinical test, and any other appro-
priate 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 
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‘‘(bb) notify health profes-
sionals and other user facilities of 
the order to cease distribution 
and advise health care profes-
sionals 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 in-
formal 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 re-
quire a recall of such in vitro clinical 
test. If, after providing an opportunity 
for such a hearing, the Secretary de-
termines that inadequate grounds 
exist to support the actions required 
by the order, the Secretary shall ter-
minate the order within 30 days of 
the hearing. Upon terminating an 
order, the Secretary shall provide 
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written notice of such termination to 
the developer. 
‘‘(vii) AMENDMENT TO REQUIRE RE-
CALL.—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 time-
frame in which the in vitro clinical test re-
call will occur and shall require periodic re-
ports to the Secretary describing the 
progress of the recall. Upon termination of 
the recall, the Secretary shall provide writ-
ten notice of such termination to the devel-
oper. 
‘‘(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, pro-
vided that the in vitro clinical test is devel-
oped and offered for clinical use in accord-
ance with such approval. 
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‘‘(I) validates such in vitro clin-
ical test prior to use; 
‘‘(II) notifies the Secretary of the 
assay validation; and 
‘‘(III) submits an emergency use 
authorization application under sec-
tion 564 within 15 calendar days of 
marketing the test. 
‘‘(C) DISPOSITION OF PRODUCT.—With re-
spect to a previously unapproved in vitro clin-
ical test or an in vitro clinical test with an un-
approved use, for which an emergency use au-
thorization 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 RE-
VIEW.—A developer may include any data or in-
formation 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, 
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including tests that are approved under section 
587B, cleared pursuant to an active technology cer-
tification order under section 587D, or exempt from 
premarket review under an exemption in this sec-
tion, shall be eligible for introduction into interstate 
commerce except as otherwise provided in this sub-
chapter. 
‘‘(b) COMPONENTS AND PARTS.— 
‘‘(1) EXEMPTION.— 
‘‘(A) IN
GENERAL.—Subject to subpara-
graph (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 
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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 pur-
poses of such paragraph) if— 
‘‘(A) it is intended solely for use in the de-
velopment of another in vitro clinical test; and 
‘‘(B) in the case of such a test that is in-
troduced 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 prod-
uct is intended solely for further development of 
an in vitro clinical test and is exempt from 
FDA regulation. This product must be evalu-
ated 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.— 
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‘‘(1) EXEMPTION.—An in vitro clinical test that 
meets the criteria set forth in paragraph (2) is ex-
empt from the requirements of this subchapter, ex-
cept as provided under subsection (a)(4), the reg-
istration 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 Lead-
ing-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 dem-
onstrating that the test meets and con-
tinues to meet the criteria set forth in 
paragraph (2); and 
‘‘(ii) makes such documentation avail-
able to the Secretary upon request. 
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‘‘(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 De-
velopment Act of 2021; 
‘‘(ii) was developed by a clinical laboratory 
for which a certificate was in effect under sec-
tion 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 sec-
tion 353 within the same corporate organi-
zation 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 Con-
trol and Prevention; 
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‘‘(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 Lead-
ing-edge IVCT Development Act of 2021 by its 
initial developer (or another person) in a man-
ner such that the test is a new in vitro clinical 
test under subsection (l). 
‘‘(3) MODIFICATIONS.—In the case of a modi-
fication 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 in-
spection. 
‘‘(d) TESTS EXEMPT FROM SECTION 510(k).— 
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‘‘(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 en-
actment 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 submis-
sion of a report under section 510(k) as of such 
date of enactment (including class II devices 
and excluding class I devices described in sec-
tion 510(l)). 
‘‘(2) EFFECT ON SPECIAL CONTROLS.—For any 
in vitro clinical test, or category of in vitro clinical 
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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 cat-
egory 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 ex-
tent 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 indi-
cating 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 sec-
tion 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-pa-
tient testing (point of care). 
‘‘(e) LOW-RISK TESTS.— 
‘‘(1) EXEMPTION.—An in vitro clinical test is 
exempt from premarket review under section 587B 
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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 subpara-
graph (A) shall consist of— 
‘‘(i) all in vitro clinical tests and cat-
egories of in vitro clinical tests that are ex-
empt from premarket review pursuant to 
subsection (d)(1) or (d)(3); and 
‘‘(ii) all in vitro clinical tests and cat-
egories 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
CAT-
EGORIES.—Without regard to subchapter II of 
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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 cat-
egories 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 ini-
tiative or in response to a request by any per-
son. 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 Sec-
retary determines to be relevant to the pro-
tection 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 inter-
mediate or final interpretation, by a qualified labora-
tory professional, and such in vitro clinical test— 
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‘‘(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 re-
quirements 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, do-
nations, and recipients of blood, blood compo-
nents, human cells, tissues, cellular-based prod-
ucts, or tissue-based products. 
‘‘(2) HIGH-RISK TEST LIMITATION OR CONDI-
TION.—A high-risk test may be exempt under para-
graph (1) from the requirements of this subchapter 
only if— 
‘‘(A) no component or part of such test, in-
cluding any reagent, is introduced into inter-
state commerce under the exemption under sub-
section (b)(1) (relating to components or parts 
intended for further development), and any ar-
ticle for taking or deriving specimens from the 
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human body used in conjunction with the test 
remains subject to the requirements of this sub-
chapter; or 
‘‘(B) the test has been developed in accord-
ance 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 deter-
mined 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 special-
ized medical journals, textbooks, special-
ized medical society proceedings, govern-
mental statistics publications, or, if no 
such studies or literature citations exist, 
credible conclusions from appropriate re-
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search or surveys) demonstrating that such 
test meets and continues to meet the cri-
teria described in this paragraph; and 
‘‘(ii) makes such documentation avail-
able 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 sec-
tion 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 devel-
oped 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 modi-
fied to diagnose a unique pathology or physical 
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condition of a specific patient for which no 
other in vitro clinical test is commercially avail-
able in the United States, and is— 
‘‘(i) not intended for use with respect 
to other patients; and 
‘‘(ii) after the development of the cus-
tom 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 
dem-
onstrating 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 Sec-
retary 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.— 
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‘‘(1) IN GENERAL.—The provisions of this sub-
chapter shall not apply to a test intended by the de-
veloper to be used solely for public health surveil-
lance activities, including the collection and testing 
of information or biospecimens, conducted, sup-
ported, requested, ordered, required, or authorized 
by a public health authority. 
‘‘(2) LIMITATION.—The public health surveil-
lance activities described in paragraph (1)— 
‘‘(A) are limited to activities necessary to 
allow a public health authority to identify, mon-
itor, assess, or investigate potential public 
health signals, onsets of disease outbreaks, or 
conditions of public health importance (includ-
ing trends, risk factors, patterns in diseases, 
and increases in injuries from using consumer 
products); and 
‘‘(B) include activities associated with pro-
viding timely situational awareness and priority 
setting during the course of a threat to the pub-
lic health (including natural or man-made dis-
asters and deliberate attacks on the United 
States). 
‘‘(3) EXCLUSION.—An in vitro clinical test is 
not excluded from the provisions of this subchapter 
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if such test is intended for use in making clinical de-
cisions 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 individ-
ually identifiable results may be reported back to an indi-
vidual 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 TECH-
NOLOGY 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— 
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‘‘(A) affects the analytical or clinical valid-
ity of such test; 
‘‘(B) causes the test to no longer comply 
with applicable mitigating measures under sec-
tion 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 sec-
tion 201(ss)(1). 
‘‘(2) 
EXEMPTIONS.—Notwithstanding 
para-
graph (1), an in vitro clinical test that is modified 
by the initial developer of the test or a different per-
son is not a new in vitro clinical test if the modifica-
tion— 
‘‘(A) is a software update that does not 
have an adverse effect on the analytical or clin-
ical validity or result in an increased risk to pa-
tients and consumers; 
‘‘(B) is made pursuant to methods or cri-
teria included in the change protocol premarket 
submission, amendment, or supplement ap-
proved by the Secretary for the in vitro clinical 
test being modified; 
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‘‘(C) is a labeling change that is appro-
priate to address patient or user harm; or 
‘‘(D) is a specimen-related modification 
that— 
‘‘(i) is made to extend specimen sta-
bility; or 
‘‘(ii) aligns with the data and infor-
mation submitted in an approved applica-
tion for premarket review under section 
587B or a technology certification order 
issued under section 587D. 
‘‘(3) DOCUMENTATION.—When a person modi-
fies 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 individ-
ually and collectively, was not a type of modi-
fication described in paragraph (1); and 
‘‘(B) provides such documentation to the 
Secretary upon request or inspection. 
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‘‘(m) INVESTIGATIONAL USE.—An in vitro clinical 
test for investigational use is exempt from the require-
ments of this Act, except as provided in section 587R. 
‘‘(n) TRANSFER OR SALE OF IN VITRO CLINICAL 
TESTS.— 
‘‘(1) TRANSFER
AND
ASSUMPTION
OF
REGU-
LATORY OBLIGATIONS.—If ownership of an in vitro 
clinical test is sold or transferred in such manner 
that the developer transfers the regulatory submis-
sions and obligations applicable under this sub-
chapter 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 clin-
ical test. 
‘‘(2) TRANSFER OR SALE OF PREMARKET AP-
PROVAL.— 
‘‘(A) NOTICE REQUIRED.—If a developer 
of an in vitro clinical test transfers or sells the 
approval of the in vitro clinical test, the trans-
feror or seller shall— 
‘‘(i) submit a notice of the transfer or 
sale to the Secretary and update the reg-
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istration and listing information under sec-
tion 587I for the in vitro clinical test; and 
‘‘(ii) submit a supplemental applica-
tion 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 supple-
mental application under section 587B(h) if re-
quired, whichever is later. The transferee or 
purchaser shall update the registration and list-
ing 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 CER-
TIFICATION.— 
‘‘(A) REQUIREMENTS FOR TRANSFER OR 
SALE
OF
TECHNOLOGY
CERTIFICATION.—An 
unexpired technology certification can be trans-
ferred 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 re-
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quirements, 
processes 
and 
procedures 
under the scope of technology certification, 
and scope of the technology certification 
identified in the applicable technology cer-
tification order. 
‘‘(B) NOTICE REQUIRED.—If a developer 
of an in vitro clinical test transfers or sells a 
technology certification order that has not ex-
pired, the transferor or seller shall submit a no-
tice of the transfer or sale to the Secretary and 
shall update the registration and listing infor-
mation under section 587I for all in vitro clin-
ical tests covered by the technology certifi-
cation. 
‘‘(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 pur-
chaser shall update the registration and listing 
information under section 587I for the in vitro 
clinical test within 30 calendar days of the ef-
fective date of the technology certification 
transfer. 
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‘‘(D) NEW
TECHNOLOGY
CERTIFICATION 
REQUIRED.—If the requirements of subpara-
graph (A)(ii) are not met, the technology cer-
tification 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 in-
strument 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 re-
quirements 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 manu-
facturer is no longer in business, a third party with 
the ability to service such instrument. 
‘‘(p) INSTRUMENT FAMILIES.—In the case of an in-
strument family, premarket approval under section 
587B(d) of one version of the in vitro clinical test is re-
quired, and previous and updated versions of the same test 
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within such instrument family shall be deemed to be sub-
ject to the approval pursuant to that section, unless the 
Secretary determines otherwise, as set forth in guidance. 
‘‘(q) GENERAL EXEMPTION AUTHORITY.—The Sec-
retary 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 consider-
ations. 
‘‘(r) REGULATIONS.—The Secretary may issue regu-
lations to implement this subchapter. 
‘‘SEC. 587B. PREMARKET REVIEW. 
‘‘(a) IN GENERAL.—No person shall introduce or de-
liver for introduction into interstate commerce any in vitro 
clinical test, unless— 
‘‘(1) an approval of an application filed pursu-
ant 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 
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(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 pre-
market review or other information related to the fil-
ing 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 re-
quired 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 sec-
tion 587D. 
‘‘(B) REPRESENTATIVE ASSAYS FOR PRE-
MARKET APPROVAL.—With respect to a tech-
nology certification application filed under sec-
tion 587D, the representative test, as described 
in subparagraph (A), used to issue a technology 
certification order under section 587D shall be 
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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 ap-
plicant; 
‘‘(ii) the table of contents for the ap-
plication and the identification of the infor-
mation the applicant claims as trade secret 
or confidential commercial or financial in-
formation; 
‘‘(iii) a description of the test’s in-
tended use; 
‘‘(iv) an explanation regarding test 
function and any significant performance 
characteristics; and 
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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 stud-
ies described in clause (iii), including a dis-
cussion demonstrating that the data and 
information in the application constitute 
valid scientific evidence and meet the appli-
cable 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 rep-
resentative. 
‘‘(D) A bibliography of all published re-
ports reasonably known to the applicant related 
to such test and a discussion of data and infor-
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mation relevant to the evaluation of the applica-
ble standard that may be met by such test. 
‘‘(E) A statement that the applicant be-
lieves 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 applica-
tion. 
‘‘(F) Except as provided under subsection 
(d), applicable information regarding the meth-
ods used in, or the facilities or controls used 
for, the development of the test to demonstrate 
compliance with the applicable quality require-
ments under section 587J. 
‘‘(G) Information demonstrating compli-
ance with any relevant— 
‘‘(i) mitigating measures under sec-
tion 587E; and 
‘‘(ii) standards established or recog-
nized 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 es-
tablished or recognized under section 
587Q, with such standards. 
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‘‘(H) Valid scientific evidence to support 
analytical and clinical validity of the test, which 
shall include— 
‘‘(i) summary information for all sup-
porting 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 Fed-
eral Regulations (or any successor regula-
tions); 
‘‘(iii) for nonclinical laboratory studies 
involving the test, a statement that studies 
were conducted in compliance with applica-
ble good laboratory practices; and 
‘‘(iv) 
for 
investigations 
involving 
human subjects, statements that any clin-
ical investigation involving human subjects 
was conducted in compliance with applica-
ble— 
‘‘(I) institutional review board 
regulations; 
‘‘(II) informed consent regula-
tions; and 
‘‘(III) investigational use require-
ments in section 587R. 
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‘‘(I) To the extent the application seeks 
authorization to make modifications to the test 
within the scope of the approval, a change pro-
tocol 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 sub-
section (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 pre-
market 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 SPE-
CIAL PREMARKET APPLICATION.—If, after receipt of 
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an application under this section, the Secretary re-
fuses to file such application, the Secretary shall 
provide to the developer, within 60 calendar days of 
receipt of such application, a description of the rea-
son for such refusal, and identify the information re-
quired, if any, to allow for the filing of the applica-
tion. 
‘‘(5) SUBSTANTIVE REVIEW FOR DEFICIENT AP-
PLICATION.—If, after receipt of an application under 
this section, the Secretary determines that any por-
tion 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 re-
quired 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 
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‘‘(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 miti-
gating measures. 
‘‘(2) APPLICATION
CONTENT.—An application 
under paragraph (1) shall include— 
‘‘(A) the information required for applica-
tions submitted under subsection (c)(2), except 
that applications under paragraph (1) need not 
include— 
‘‘(i) quality requirement information; 
or 
‘‘(ii) raw data unless explicitly re-
quested by the Secretary; 
‘‘(B) in the case of a specimen receptacle, 
safety information; and 
‘‘(C) data, as applicable, to support soft-
ware validation, electromagnetic compatibility, 
and electrical safety, and information dem-
onstrating compliance with maintaining quality 
systems documentation. 
‘‘(3) INSPECTIONS.—With respect to an appli-
cation under paragraph (1), preapproval inspections 
authorized by an employee of the Food and Drug 
Administration or a person accredited under section 
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587P need not occur unless requested by the Sec-
retary. 
‘‘(e) INSTRUMENT FAMILY.—When an in vitro clin-
ical test has been approved, or is otherwise legally mar-
keted, 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 sub-
section (c) or (d). 
‘‘(2) REQUIRED
AMENDMENT
OR
SUPPLE-
MENT.—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 SUPPLE-
MENT.—The Secretary may request that an appli-
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cant amend or supplement an application under sub-
section (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 pos-
sible, 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 appli-
cation under subsection (d) is accepted for sub-
mission, the Secretary, after considering any 
applicable report and recommendations pursu-
ant to advisory committees under section 587G, 
or prior to the establishment of such advisory 
committees, any recommendations by a classi-
fication panel under section 513, shall issue an 
order approving the application, unless the Sec-
retary finds that the grounds for approval in 
paragraph (2) are not met. 
‘‘(B) RELIANCE
ON
PROPOSED
LABEL-
ING.—In determining whether to approve or 
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deny an application under paragraph (1), the 
Secretary shall rely on the intended use in-
cluded 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 sub-
section (c) with respect to an in vitro clinical 
test if the Secretary finds that there is a rea-
sonable assurance that the applicable standard 
is met, and— 
‘‘(i) except as provided under sub-
section (d), the applicant is in compliance 
with applicable quality requirements in sec-
tion 587J or as otherwise specified in a 
condition of approval, or maintains the 
documentation required to be in compli-
ance with such requirements if the appli-
cant is not required to submit such docu-
mentation as a part of the application 
under this section; 
‘‘(ii) the application does not contain 
a false statement of material fact; 
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‘‘(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 sub-
section (d), the applicant permits, if re-
quested, authorized employees of the Food 
and Drug Administration and persons ac-
credited under section 587P an oppor-
tunity— 
‘‘(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, in-
cluding 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 ap-
plication and the in vitro clinical test; 
‘‘(v) the test conforms with any appli-
cable performance standards under section 
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587Q and any applicable mitigating meas-
ures under section 587E; and 
‘‘(vi) all nonclinical laboratory studies 
and clinical investigations involving human 
subjects that are described in the applica-
tion 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 conform-
ance 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 approv-
ing an application pursuant to this paragraph— 
‘‘(i) may impose requirements for 
tests with the same indications for use, in-
cluding conformance with performance 
standards under section 587Q and miti-
gating measures under section 587E, and 
comply with restrictions under section 
587N; and 
‘‘(ii) shall indicate whether subsequent 
in vitro clinical tests with the same in-
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tended 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 disclo-
sure 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 sec-
tion 587O. 
‘‘(h) SUPPLEMENTS TO AN APPLICATION.— 
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‘‘(1) RISK
ANALYSIS.—Prior to implementing 
any modification to an in vitro clinical test, the hold-
er of the application approved under subsection (c) 
or (d) for such test shall perform risk analyses in 
accordance with section 587J, unless such modifica-
tion is included in the change protocol submitted by 
the applicant and approved under this section or ex-
empt 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 ap-
proved under subsection (g) for an in vitro clin-
ical test shall submit to the Secretary and re-
ceive approval of a supplement before imple-
menting a modification to the test, unless such 
modification is exempt under section 587A(l). 
‘‘(B) ADJUSTMENTS
TO
CHANGE
PRO-
TOCOL.—A person may submit under this para-
graph 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 subpara-
graphs (D) and (E), and so long as the holder 
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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, with-
out prior approval of a supplement, implement 
the following modifications to the test: 
‘‘(i) Modifications included in and im-
plemented in accordance with an approved 
change protocol under subsection (c)(2)(I). 
‘‘(ii) 
Modifications 
that 
do 
not 
change— 
‘‘(I) the analytical or clinical va-
lidity 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 appro-
priately address a safety concern. 
‘‘(iv) Modifications that are exempt 
under section 587A(l). 
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‘‘(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 sub-
paragraph (C) in the next annual report 
for the test under subsection (k) following 
the date on which the test, with such modi-
fication, is introduced into interstate com-
merce; and 
‘‘(ii) include in such report— 
‘‘(I) a description of the modi-
fication; and 
‘‘(II) as applicable, a summary of 
the analytical validity and clinical va-
lidity 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 modi-
fication to the test described in clause (iii) 
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of subparagraph (C) not more than 60 
days after the date on which the test, with 
the modification, is introduced into inter-
state commerce; and 
‘‘(ii) include in the report— 
‘‘(I) a summary of the relevant 
change or changes; 
‘‘(II) the rationale for imple-
menting 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 sub-
paragraph (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 supple-
ment under subparagraph (A) is required, the 
Secretary shall notify the applicant of such de-
termination. 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 agen-
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cy feedback as to the necessity of such supple-
mental filing. The Secretary shall respond to 
such meeting request within 30 calendar days 
of receipt. 
‘‘(3) CONTENTS OF SUPPLEMENT.—Unless oth-
erwise specified by the Secretary, a supplement 
under this subsection shall include— 
‘‘(A) for modifications other than manufac-
turing site changes— 
‘‘(i) a description of the modification; 
‘‘(ii) data to demonstrate that the ap-
plicable standard is met; 
‘‘(iii) acceptance criteria; and 
‘‘(iv) any revised labeling; and 
‘‘(B) for manufacturing site changes— 
‘‘(i) the information listed in subpara-
graph (A); and 
‘‘(ii) information regarding the meth-
ods 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 modifica-
tion to an in vitro clinical test that is in addition to 
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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 re-
strictions 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 modi-
fied in vitro clinical test meets the applicable 
standard; and 
‘‘(B) the holder of the application approved 
under subsection (g) for the test has dem-
onstrated compliance with applicable quality 
and inspection requirements, as applicable and 
appropriate. 
‘‘(7) PUBLICATION.—The Secretary shall pub-
lish on the public website of the Food and Drug Ad-
ministration notice of any order approving a supple-
ment under this subsection, except that such publi-
cation shall exclude— 
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‘‘(A) commercial confidential or trade se-
cret information; and 
‘‘(B) any other information that the Sec-
retary determines to relate to national security 
or countermeasures or to be restricted from dis-
closure 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 
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‘‘(ii) there is a reasonable likelihood 
that the test would cause death or serious 
adverse health consequences, including by 
causing the absence, delay, or discontinu-
ation of life-saving or life sustaining med-
ical treatment. 
‘‘(B) CONTENT.—An order under subpara-
graph (A) withdrawing approval of an applica-
tion 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 Ad-
ministration, 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 re-
stricted from disclosure pursuant to an-
other provision of law. 
‘‘(2) ORDER OF TEMPORARY SUSPENSION.—If, 
after providing due notice and an opportunity for an 
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informal hearing to the holder of an approved appli-
cation for an in vitro clinical test under this section, 
the Secretary determines there is a reasonable likeli-
hood 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 Sec-
retary shall by order temporarily suspend the ap-
proval of the application. If the Secretary issues 
such an order, the Secretary shall proceed expedi-
tiously under paragraph (1) to withdraw approval of 
such application. 
‘‘(j) LEAST BURDENSOME REQUIREMENTS.— 
‘‘(1) IN GENERAL.—In carrying out this sub-
chapter, the Secretary shall consider the least bur-
densome means necessary to provide a reasonable 
assurance of analytical and clinical validity, or appli-
cable standard, and other regulatory requirements, 
as determined by the Secretary. 
‘‘(2) NECESSARY DEFINED.—For purposes of 
paragraph (1) and paragraph (3), the term ‘nec-
essary’ 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 
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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 bur-
densome appropriate means necessary to dem-
onstrate that the applicable standard and other reg-
ulatory requirements have been met. 
‘‘(k) ANNUAL REPORT.— 
‘‘(1) IN GENERAL.—Unless the Secretary speci-
fies 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 ap-
proval order, including any modification that 
requires a supplement under subsection (h)(2); 
and 
‘‘(B) include any other information re-
quired by the Secretary. 
‘‘(2) EXCEPTION.—The annual reporting re-
quirement in paragraph (1) shall not apply to in 
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vitro clinical tests that are deemed to have a pre-
market 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 sub-
section (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 des-
ignated 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 break-
through 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, 
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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 treat-
ment 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 tech-
nology; 
‘‘(B) for which no approved or precertified 
alternative exists; 
‘‘(C) that offers a clinically meaningful ad-
vantage over existing approved or precertified 
alternatives, including the potential, compared 
to existing approved or precertified alternatives, 
to reduce or eliminate the need for hospitaliza-
tion, 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. 
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‘‘(d) DESIGNATION.— 
‘‘(1) REQUEST.—To receive breakthrough ap-
proval 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 dem-
onstrating that the test is eligible for designation 
under subsection (c). 
‘‘(2) DETERMINATION.—Not later than 60 cal-
endar days after the receipt of a request under para-
graph (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 para-
graph (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 
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deemed to be withdrawn, and such in vitro clin-
ical test shall no longer be eligible for designa-
tion under this section, if an application for ap-
proval under section 587B is denied. Such test 
shall be eligible for designation upon a new re-
quest for such designation. 
‘‘(B) EXCEPTION.—The Secretary may not 
withdraw a designation granted under this sub-
section 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 devel-
opment and review of in vitro clinical tests under this sec-
tion, 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 ref-
erence 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.— 
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‘‘(1) IN GENERAL.—Not later than one year 
after the date of enactment of the Verifying Accu-
rate Leading-edge IVCT Development Act of 2021, 
the Secretary shall issue draft guidance on the im-
plementation of this section. Such guidance shall— 
‘‘(A) set forth the process by which a per-
son 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, in-
cluding 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 effi-
cient review. 
‘‘(2) PROCESS.—Prior to finalizing the guid-
ance under paragraph (1), the Secretary shall seek 
public comment on the draft guidance. The Sec-
retary shall issue final guidance one year after the 
close of the comment period for the draft guidance. 
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‘‘(g) ANNUAL REPORT.—Unless otherwise specified 
by the Secretary, the requirements under section 587B(k) 
apply to in vitro clinical tests designated under this sec-
tion. 
‘‘(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 des-
ignated 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 
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‘‘(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 per-
son— 
‘‘(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 certifi-
cations under section 353 of the Public Health 
Service Act, as applicable; or 
‘‘(C) has been found to have submitted in-
formation to the Secretary that— 
‘‘(i) makes false or misleading state-
ments about a technology certification 
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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 pre-
market 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 sec-
tion 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 re-
cipients 
of 
blood, 
blood 
components, 
human cells, tissues, cellular-based prod-
ucts, or tissue-based products; or 
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‘‘(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 clin-
ical tests, cross-referenced in vitro clinical 
tests, and direct-to-consumer in vitro clin-
ical tests. 
‘‘(c) PUBLIC MEETING AND INPUT.— 
‘‘(1) PUBLIC DOCKET.—Not later than 30 days 
after the date of enactment of the Verifying Accu-
rate Leading-edge IVCT Development Act of 2021, 
the Secretary shall establish a public docket to re-
ceive comments concerning recommendations for im-
plementation of this section, including criteria and 
procedures for subsections (e) through (j). The pub-
lic 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 rep-
resenting patients and consumers, academia, and the 
in vitro clinical test industry are invited in order to 
discuss the technology certification process including 
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application requirements, inspections, alignment 
with third-party accreditors, and the definition of 
‘technology’ under section 587(17). 
‘‘(d) REGULATIONS.—The Secretary shall issue regu-
lations on technology certification including describing cri-
teria or procedures relating to technology certification 
under this section, which shall be subject to public com-
ment 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 ap-
plication and recertification process, opportunities to meet 
with officials of the Food and Drug Administration and 
plans to streamline inspections. 
‘‘(e) APPLICATION
FOR
TECHNOLOGY
CERTIFI-
CATION.— 
‘‘(1) IN GENERAL.—A person seeking a tech-
nology certification order shall submit an application 
under this subsection, which shall contain the infor-
mation specified under paragraph (2). 
‘‘(2) CONTENT OF APPLICATION.—An applica-
tion 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 in-
tended to be offered under the application; 
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‘‘(B) information describing that the per-
son seeking a technology certification order is 
an eligible person under subsection (b)(1); 
‘‘(C) information describing that the meth-
ods used in, and the facilities and controls used 
for, the development of eligible in vitro clinical 
tests covered by the scope of the technology cer-
tification conform to the applicable quality re-
quirements of section 587J; 
‘‘(D) procedures for analytical validation, 
including 
all 
procedures 
for 
validation, 
verification, and acceptance criteria, and an ex-
planation as to how such procedures, when 
used, provide a reasonable assurance of analyt-
ical validity of eligible in vitro clinical tests 
within the proposed scope of the technology cer-
tification order; 
‘‘(E) procedures for clinical validation, in-
cluding 
all 
procedures 
for 
validation, 
verification, and acceptance criteria, and an ex-
planation 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 certifi-
cation order; 
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‘‘(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 rep-
resentative test and validate and run with-
in the developer’s stated scope; 
‘‘(ii) the information specified in sub-
section (c) or (d) of section 587B, as appli-
cable, for the representative in vitro clin-
ical test or tests, including information and 
data required pursuant to subsection 
(c)(2)(H) of section 587B, unless the Sec-
retary 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 appli-
cation and how such test adequately dem-
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onstrates 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 ap-
plication under subparagraphs (C), (D), 
(E), and (F) have been applied to the rep-
resentative in vitro clinical test or tests; 
‘‘(H) such other information as the Sec-
retary 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 Sec-
retary 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 certifi-
cation application described in paragraph (2), a de-
veloper 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.— 
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‘‘(A) IN GENERAL.—As promptly as prac-
ticable, and no later than 90 days after receipt 
of an application under subsection (c), the Sec-
retary shall— 
‘‘(i) issue a technology certification 
order granting the application, which shall 
specify the scope of the technology certifi-
cation, if the Secretary finds that all of the 
grounds in paragraph (3) are met; or 
‘‘(ii) deny the application if the Sec-
retary 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 para-
graph (3) are not met. 
‘‘(B) EXTENSION.—The timeline described 
in subparagraph (A) may be extended by mu-
tual 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 re-
ceipt of such application, shall provide to the 
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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 infor-
mation submitted to the Secretary as part of the ap-
plication 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 as-
surance 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 as-
surance of clinical validity for eligible in vitro 
clinical tests within the proposed scope of the 
technology certification, as evidenced by the 
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clinical program, including procedures for clin-
ical 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 ma-
terial 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 represent-
ative 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 applica-
tion, as applicable; and 
‘‘(G) the applicant permits authorized em-
ployees of the Food and Drug Administration 
or persons accredited under this Act an oppor-
tunity to inspect at a reasonable time and in a 
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reasonable manner the facilities and all perti-
nent equipment, finished and unfinished mate-
rials, 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 author-
ized 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, in-
cluding an application for renewal under subsection 
(g), the Secretary will provide a summary of defi-
ciencies 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 cal-
endar days after the date upon which such applicant 
receives notice of such denial, obtain review thereof 
in accordance with section 587O. 
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‘‘(g) DURATION; SUBSEQUENT SUBMISSIONS.— 
‘‘(1) ORDER DURATION.—A technology certifi-
cation order shall remain in effect until the earlier 
of— 
‘‘(A) the expiration of such technology cer-
tification 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 Sec-
retary that is not later than 4 years after the 
date that such technology certification order is 
issued. 
‘‘(B) In the event of expiration of tech-
nology certification order, the clearance of tests 
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introduced into interstate commerce under such 
order prior to its expiration pursuant to sub-
section (f)(3) remain in effect. 
‘‘(3) RENEWAL.— 
‘‘(A) IN GENERAL.—Any person previously 
granted a technology certification order in ef-
fect 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 supple-
ments to orders granted under paragraph 
(4). 
‘‘(B) CONTENT.—An application for re-
newal under this paragraph shall include infor-
mation concerning one or more representative 
in vitro clinical tests in accordance with sub-
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section (e)(2)(G), except that such representa-
tive test or tests shall be different from the rep-
resentative test or tests relied upon as the rep-
resentative assay in any prior technology certifi-
cation, if applicable. 
‘‘(C) PROCESS.—The Secretary’s action on 
an application for renewal of technology certifi-
cation 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 applica-
tion shall be treated as a technology certifi-
cation order for purposes of this subchapter. 
‘‘(4) SUPPLEMENTS AND REPORTS.— 
‘‘(A) SUPPLEMENTS.—Except as provided 
in subparagraph (B), any person with a tech-
nology certification order in effect may seek a 
supplement to such order upon a change or 
changes to the information provided in the ap-
plication for technology certification under sub-
paragraphs (C), (D), and (E) of subsection 
(e)(2), provided that— 
‘‘(i) such person is an eligible person 
under subsection (b)(1); and 
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‘‘(ii) such change does not expand the 
scope of the technology certification, unless 
the Secretary determines that such expan-
sion is appropriate. 
A supplement to an order may contain only in-
formation 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 cer-
tification 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— 
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‘‘(I) a summary of the relevant 
change or changes; 
‘‘(II) the rationale for imple-
menting 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 in-
consistent with the standard specified 
under this subparagraph, the Secretary 
may require a supplement under subpara-
graph (A). 
‘‘(h) MAINTENANCE REQUIREMENTS.—For the dura-
tion of a technology certification order, a holder of a tech-
nology 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; 
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‘‘(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 sub-
chapter; 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 re-
main in place until the Secretary responds to a writ-
ten 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 
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100 
notified the developer of such hold and provided 30 
calendar days for the developer to come into compli-
ance with or resolve the findings under paragraph 
(4). 
‘‘(3) WRITTEN
REQUESTS.—Any written re-
quest to the Secretary from the holder of a tech-
nology certification order that a temporary hold 
under paragraph (1) be removed shall receive a deci-
sion, 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 mainte-
nance 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 
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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 mate-
rial fact; 
‘‘(2) such holder fails to correct materially false 
or misleading labeling or advertising upon the re-
quest of the Secretary; 
‘‘(3) in connection with a technology certifi-
cation, the holder provides materially false or mis-
leading 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 Sec-
retary shall submit to the Committee on Energy and 
Commerce of the House of Representatives and the 
Committee on Health, Education, Labor, and Pen-
sions of the Senate, and make publicly available, in-
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cluding 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 cer-
tification orders in effect; and 
‘‘(v) the total number of approved 
tests under section 587B that were reclas-
sified and granted a technology certifi-
cation order under this section. 
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103 
‘‘(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 re-
ports required under this section may be issued 
with performance reports as required under sec-
tion 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
WITH-
DRAWING.— 
‘‘(A) ESTABLISHMENT.—If the Secretary 
requires the establishment of mitigating meas-
ures pursuant to clause (i) or (ii) of section 
587(15)(A) for any in vitro clinical test, the 
Secretary may require such mitigating meas-
ures for any other in vitro clinical test with the 
same indications for use. 
‘‘(B) 
PROCESS.—Notwithstanding 
sub-
chapter II of chapter 5 of title 5, United States 
Code, the Secretary may— 
‘‘(i) establish, change, or withdraw 
mitigating measures by— 
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‘‘(I) publishing a proposed ad-
ministrative order in the Federal Reg-
ister; 
‘‘(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 Fed-
eral Register; and 
‘‘(ii) may establish mitigating meas-
ures with respect to a category in a pre-
market approval order or technology cer-
tification 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 spe-
cial controls or restrictions established during 
the period beginning on the date of enactment 
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105 
of the Verifying Accurate Leading-edge IVCT 
Development Act of 2021 and ending on the ef-
fective 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 es-
tablish, change, or withdraw mitigating meas-
ures for such a test or indications for use the 
procedures under paragraph (1). 
‘‘(b) DOCUMENTATION.— 
‘‘(1) TESTS
SUBJECT
TO
PREMARKET
RE-
VIEW.—The developer of an in vitro clinical test sub-
ject 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; 
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106 
‘‘(B) if such application is approved, main-
tain documentation demonstrating that such 
mitigating measures continue to be met fol-
lowing a test modification by the developer; and 
‘‘(C) after responding to any informal com-
munications 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 exemp-
tion from premarket review under section 587B and 
to which mitigating measures apply shall— 
‘‘(A) maintain documentation in accord-
ance with the applicable quality requirements 
under section 587J demonstrating that such 
mitigating measures continue to be met fol-
lowing 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. 
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107 
‘‘(c) MITIGATING
MEASURES
FOR
CROSS-REF-
ERENCED TESTS.—Not later than 1 year after the imple-
mentation of the Verifying Accurate Leading-edge IVCT 
Development Act of 2021, the Secretary shall issue miti-
gating 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 pe-
tition 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 
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108 
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 sub-
section shall be made by publication of a notice of 
such proposed action in the Federal Register, con-
sideration 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 ad-
visory committees or use advisory committee panels of ex-
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109 
perts established before the date of enactment of this sec-
tion 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 clin-
ical tests; 
‘‘(2) the potential effectiveness of mitigating 
measures for a determination on the applicable regu-
latory pathway under section 587F or risk evalua-
tion 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 de-
termines appropriate. 
‘‘(b) APPOINTMENTS.— 
‘‘(1) VOTING MEMBERS.—The Secretary shall 
appoint to each committee established under sub-
section (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 indi-
viduals with, to the extent feasible, scientific exper-
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110 
tise 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 estab-
lished under subsection (a), as nonvoting members— 
‘‘(A) a representative of consumer inter-
ests; and 
‘‘(B) a representative of interests of in 
vitro clinical test developers not directly af-
fected 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 Sec-
retary shall, as appropriate, provide education and 
training to each new committee member before such 
member participates in a committee’s activities, in-
cluding education regarding requirements under this 
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111 
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 com-
munication to convene the meetings. 
‘‘(6) COMPENSATION.—Members of an advisory 
committee established under subsection (a), while at-
tending meetings or conferences or otherwise en-
gaged in the business of the advisory committee— 
‘‘(A) shall be entitled to receive compensa-
tion 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 au-
thorized by section 5703 of title 5, United 
States Code, for employees serving intermit-
tently in the Government service. 
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‘‘(c) GUIDANCE.—The Secretary may issue guidance 
on the policies and procedures governing advisory commit-
tees established under subsection (a). 
‘‘SEC. 587H. REQUEST FOR INFORMAL FEEDBACK. 
‘‘Before submitting a premarket application or tech-
nology 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, con-
ference, 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 dem-
onstrate the applicable standard; 
‘‘(B) which regulatory pathway is appro-
priate 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 Sec-
retary 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 
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‘‘(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 sec-
tion 587P, acting on behalf of such a person, shall— 
‘‘(A) during the period beginning on Octo-
ber 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 es-
tablishments engaged in the activities specified 
under this paragraph, the establishment reg-
istration number of each such establishment, 
and a point of contact for each such establish-
ment, including an electronic point of contact; 
and 
‘‘(B) submit an initial registration con-
taining the information required under subpara-
graph (A) not later than— 
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‘‘(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 guid-
ance a date later than such implementation 
date for all or a category of such establish-
ments; or 
‘‘(ii) 30 days prior to engaging in any 
activity described in subsection (b)(1) after 
enactment of this section, if such establish-
ment is not engaged in any activity de-
scribed 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 estab-
lishment 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 accord-
ance with subsection (d). 
‘‘(3) INSPECTION.—Each person or establish-
ment that is required to be registered with the Sec-
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retary under this section shall be subject to inspec-
tion pursuant to section 704. 
‘‘(b) LISTING INFORMATION FOR IN VITRO CLINICAL 
TESTS.— 
‘‘(1) IN GENERAL.—Each person who— 
‘‘(A) is a developer, a contract manufac-
turer (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 sec-
tion 587B or 587D, 
shall submit a listing to the Secretary containing the 
information described in paragraph (2) in accord-
ance 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 
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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 es-
tablishment 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 lab-
oratory 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 num-
ber 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 cer-
tification o, or offered as an in vitro clinical test 
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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, re-
strictions, 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 num-
bers 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 
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pursuant to subsection (a) shall submit an abbre-
viated listing to the Secretary containing the infor-
mation 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 sub-
section (c). Such abbreviated listing shall be pre-
pared in such form and manner as the Secretary 
may specify in guidance. Listing information shall be 
submitted to the comprehensive test information sys-
tem in accordance with section 587T, as appro-
priate. 
‘‘(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 list-
ing 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 
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under section 587A may submit listing information 
under this subsection. 
‘‘(c) TIMELINES FOR SUBMISSION.— 
‘‘(1) IN GENERAL.—The timelines for submis-
sion 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 submit-
ting 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 submit-
ting the notification under this section becomes 
available. 
‘‘(B) For an in vitro clinical test that is 
subject to the grandfathering provisions of sec-
tion 587A(c), a person shall submit the listing 
information required under subsection (b)(5) no 
later than 1 year after the system for submit-
ting the notification under this section becomes 
available. 
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‘‘(C) For an in vitro clinical test that is 
not described in subparagraph (A) or (B), a 
person shall submit the required notification in-
formation prior to offering, introducing, or mar-
keting 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 ap-
proval of the premarket approval applica-
tion. 
‘‘(ii) For a developer who has received 
a technology certification order under sec-
tion 587D, a person shall submit the re-
quired listing information at least 30 busi-
ness 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 informa-
tion within 10 business days of any change that 
causes any previously notified information to be 
inaccurate or incomplete. 
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‘‘(B) ANNUAL UPDATES.—Each developer 
required to submit listing information under 
this section shall update its information annu-
ally 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 IN-
FORMATION.— 
‘‘(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 informa-
tion 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 ap-
proval or the developer receives a technology certifi-
cation order. 
‘‘(3) EXCEPTIONS FROM PUBLIC AVAILABILITY 
REQUIREMENTS.—The registration and listing infor-
mation requirements described in subsections (a) 
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and (b) shall not apply to the extent the Secretary 
determines that such information relates to— 
‘‘(A) trade secret or commercial confiden-
tial information; or 
‘‘(B) national security or countermeasures 
or is restricted from disclosure pursuant to an-
other provision of law. 
‘‘(e) SUBMISSION OF INFORMATION BY ACCREDITED 
PERSONS.—If agreed upon by the developer, the informa-
tion 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 re-
quirements in accordance with the applicable re-
quirements set forth in subsection (b), except as pro-
vided in section 587A. 
‘‘(2) 
CERTIFIED
LABORATORY
REQUIRE-
MENTS.—A developer that operates a clinical labora-
tory certified by the Secretary under section 353 of 
the Public Health Service Act that— 
‘‘(A) meets the requirements for per-
forming high-complexity testing; 
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