I 
116TH CONGRESS 
2D SESSION 
H. R. 6102 
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 
MARCH 5, 2020 
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 2020’’ or the ‘‘VALID Act of 2020’’. 
(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 
‘‘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) an article for taking, deriving, hold-
ing, or transporting specimens from the human 
body (as defined in section 587(16)); 
‘‘(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 
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‘‘(v) subject to subparagraph (2), a compo-
nent or part of a test, a test protocol, an instru-
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, means that an undetected inac-
curate result from such test or category— 
‘‘(i) presents potential unreasonable 
risk for serious or irreversible harm or 
death to a patient or patients, or would 
otherwise cause serious harm to the public 
health; or 
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‘‘(ii) is potentially likely to result in 
the absence, delay, or discontinuation of 
life-supporting or life-sustaining medical 
treatment. 
‘‘(B) EXCEPTION.—The term ‘high-risk’ 
does not include an in vitro clinical test de-
scribed in subparagraph (A) if mitigating meas-
ures are established and applied to sufficiently 
mitigate the risk of inaccurate results as de-
scribed in subparagraph (A), including— 
‘‘(i) the degree to which the tech-
nology for the intended use of the in vitro 
clinical test is well-characterized, and the 
criteria for performance of the test are 
well-established to be sufficient for the in-
tended use; and 
‘‘(ii) the clinical circumstances under 
which the in vitro clinical test is used, and 
the availability of other tests (such as con-
firmatory or adjunctive tests) or relevant 
material standards. 
‘‘(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: 
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‘‘(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 
which the developer demonstrates and documents, 
with respect to all such instruments, that all— 
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‘‘(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— 
‘‘(i) performing pre-analytical and 
post-analytical processes for an in vitro 
clinical test; 
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‘‘(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— 
‘‘(A) an undetected inaccurate result from 
such in vitro clinical test, or such category of 
in vitro clinical tests, when used as intended— 
‘‘(i) would cause minimal or no harm, 
or minimal or no disability, or immediately 
reversible harm, or would lead to only a re-
mote risk of adverse patient impact or ad-
verse public health impact; or 
‘‘(ii) could cause non-life threatening 
injury, harm that is medically reversible, or 
a delay in necessary treatment; or 
‘‘(B) mitigating measures are sufficient to 
ensure the test meets the requirements of sub-
paragraph (A) 
‘‘(15) 
MITIGATING
MEASURES.—The 
term 
‘mitigating measures’— 
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‘‘(A) means requirements that the Sec-
retary determines, based on available evidence, 
are necessary— 
‘‘(i) for an in vitro clinical test, or a 
category of in vitro clinical tests, to meet 
the applicable standard; or 
‘‘(ii) to mitigate the risk of harm en-
suing from an inaccurate result or mis-
interpretation of any result; and 
‘‘(B) includes, as appropriate, applicable 
requirements regarding labeling, performance 
standards, performance testing, submission of 
clinical data, advertising, website posting of in-
formation, clinical studies, postmarket surveil-
lance, user comprehension studies, training, and 
conformance to standards. 
‘‘(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-
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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 
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— 
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‘‘(i) that has been generated and eval-
uated by persons qualified by training or 
experience to do so, using procedures gen-
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 
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‘‘(xiii) data collected in countries 
other than the United States if such data 
are demonstrated to be adequate for the 
purpose of making a regulatory 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.— 
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‘‘(A) IN
GENERAL.—An in vitro clinical 
test shall be subject to the requirements of this 
subchapter, except as otherwise provided this 
subchapter. 
‘‘(B) INTERSTATE
COMMERCE.—Any in 
vitro clinical test that is offered for clinical use 
in the United States is deemed to be introduced 
into interstate commerce for purposes of 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. 
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‘‘(2) LABORATORIES AND BLOOD AND TISSUE 
ESTABLISHMENTS.— 
‘‘(A) RELATION TO LABORATORY CERTIFI-
CATION
PURSUANT
TO
SECTION
353
OF
THE 
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.— 
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‘‘(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 
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), 
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and (k) an in vitro clinical test (including any 
article for taking or deriving specimens) shall 
be subject to the requirements of section 587B 
if the Secretary determines, in accordance with 
subparagraph (B), that— 
‘‘(i)(I) there is insufficient valid 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.— 
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‘‘(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— 
‘‘(I) pertaining to such criteria; 
and 
‘‘(II) establishing the basis for 
any claimed exemption from pre-
market review. 
‘‘(ii) DEADLINE FOR SUBMITTING IN-
FORMATION.—Upon receiving a request for 
information under clause (i), the developer 
of an in vitro clinical test shall submit the 
information within 30 days of such receipt. 
‘‘(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. 
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‘‘(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— 
‘‘(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 
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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. 
‘‘(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— 
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‘‘(aa) cease distribution of 
the test pending approval of an 
application for premarket review 
of the test under section 587B; 
and 
‘‘(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 
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by the order, the Secretary shall ter-
minate the order within 30 days of 
the hearing. Upon terminating an 
order, the Secretary shall provide 
written notice of such termination to 
the developer. 
‘‘(vii) AMENDMENT TO REQUIRE 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-
table 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 
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on efforts to pursue such authoriza-
tion; 
‘‘(II) validates such in vitro clin-
ical test prior to use; 
‘‘(III) notifies the Secretary of 
the assay validation; and 
‘‘(IV) includes a statement to-
gether with the results of the test that 
reads: ‘This IVCT was developed for 
use as a part of a response to a public 
health emergency. This test has not 
been reviewed by the Food and Drug 
Administration.’. 
‘‘(C) DISPOSITION OF PRODUCT.—With re-
spect to a previously unapproved in vitro clin-
ical test or an in vitro clinical tests 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 
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part of a premarket application under section 
587B or a technology certification application 
under section 587D. 
‘‘(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)(F) is exempt 
from the requirements of this subchapter if it 
is— 
‘‘(i) intended for further development 
as described in paragraph (2); or 
‘‘(ii) is otherwise to be regulated 
based on its risk when used as intended by 
the developer, notwithstanding its subse-
quent use by a developer as a component, 
part, or raw material of another in vitro 
clinical test. 
‘‘(B) 
INAPPLICABILITY
TO
OTHER 
TESTS.—Notwithstanding subparagraph (A), an 
in vitro clinical test that is described in section 
201(ss)(1)(B) and that uses a component or 
part described in such subparagraph shall be 
subject to the requirements of this subchapter, 
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unless the test is otherwise exempted 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 2020, 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.— 
‘‘(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 section 587A(a)(4), the reg-
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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 2020 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. 
‘‘(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 
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the Verifying Accurate Leading-edge IVCT De-
velopment Act of 2020; 
‘‘(ii) was developed by a clinical laboratory 
for which a certificate is in effect under section 
353 of the Public Health Service Act that 
meets the requirements under section 353 for 
performing high-complexity testing; 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; 
‘‘(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 approval under section 520(m); 
and 
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‘‘(C) is not modified on or after the date 
of enactment of the Verifying Accurate Lead-
ing-edge IVCT Development Act of 2020 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 vitro clinical test that is exempt as 
specified in paragraph (1) or determines that such 
modification is otherwise not subject to premarket 
review pursuant to section 587A(l), the test con-
tinues 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).— 
‘‘(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— 
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‘‘(A)(i) was offered for clinical use prior to 
the date of enactment of the Verifying Accurate 
Leading-edge IVCT Development Act of 2020; 
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 
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 
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Act of 2020 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 
2020, 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 
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.— 
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‘‘(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 
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 
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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 (as defined in section 
587); 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— 
‘‘(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-
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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 
human body used in conjunction with the test 
remains subject to the requirements of this sub-
chapter; or 
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‘‘(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— 
‘‘(i) is intended for use for a disease 
or condition for which no more than 
10,000 (or such other number determined 
by the Secretary) individuals would be sub-
ject to negative or positive diagnosis by 
such test in the United States per year; 
and 
‘‘(ii) is not intended to diagnose a 
contagious disease or condition that is 
highly likely to result in fatal or irrevers-
ibly debilitating outcome and for which 
prompt and accurate diagnosis offers the 
opportunity to mitigate a public health im-
pact of the condition; and 
‘‘(B) the developer of the test— 
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‘‘(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-
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-
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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 
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 
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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.— 
‘‘(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.—Such activities— 
‘‘(A) are limited to those 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, or 
increases in injuries from using consumer prod-
ucts); and 
‘‘(B) include those associated with pro-
viding timely situational awareness and priority 
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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 
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)(2), is exempt from pre-
market review under section 587B. 
‘‘(l) MODIFIED TESTS.— 
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‘‘(1) IN
GENERAL.—An in vitro clinical test 
that is modified, by the initial developer of the test 
or a different person, is a new in vitro clinical test 
subject to the requirements of this subchapter if the 
modification— 
‘‘(A) affects the analytical or clinical 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; 
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‘‘(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; 
‘‘(C) is a labeling change that is appro-
priate to address patient or user harm; or 
‘‘(D) is a specimen-related modification 
that is made to extend specimen stability or 
aligns with the data and information submitted 
in an approved application for premarket review 
under section 587B or an 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 subclause 
(A)(ii) are not met, then the technology certifi-
cation order cannot be transferred and the 
transferee or purchaser of an in vitro clinical 
test must submit an application for technology 
certification and obtain a technology certifi-
cation order prior to offering the test for clin-
ical 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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‘‘(v) an explanation of how the devel-
opment and validation activities support 
the test meeting the applicable standard. 
‘‘(B) A summary of the data and informa-
tion in the application for the in vitro clinical 
test, including— 
‘‘(i) a brief description of any existing 
alternative practices or procedures for di-
agnosing the disease or condition for which 
the in vitro clinical test is intended, as ap-
plicable; 
‘‘(ii) a brief description of the foreign 
and domestic marketing history of the test, 
if any, including a list of all countries in 
which the test has been marketed and a 
list of all countries in which the test has 
been withdrawn from marketing for any 
reason related to the applicable standard 
of the in vitro clinical test, if known by the 
applicant; 
‘‘(iii) a summary of the any studies 
submitted for such test, including a de-
scription of the objective of the study, a 
description of the experimental design of 
the study, a brief description of how the 
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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(10), an 
explanation of how the development and 
validation activities, as applicable, support 
that the test meets the applicable standard 
under section 587(10), 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 
2020, 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; and 
‘‘(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 2020, 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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