171 
sponsor may immediately appeal any such deter-
mination pursuant to section 587O. 
‘‘(2) DETERMINATION.—For purposes of para-
graph (1), a determination described in this sub-
paragraph with respect to a clinical hold is a deter-
mination that— 
‘‘(A) the in vitro clinical test involved rep-
resents an unreasonable risk to the safety of 
the persons who are the subjects of the clinical 
investigation, taking into account the qualifica-
tions of the clinical investigators, information 
about the in vitro clinical test, the design of the 
clinical investigation, the condition for which 
the in vitro clinical test is to be investigated, 
and the health status of the subjects involved; 
‘‘(B) the clinical hold should be issued for 
such other reasons as the Secretary may by 
regulation establish; or 
‘‘(C) any written request to the Secretary 
from the sponsor of an investigation that a clin-
ical hold be removed shall receive a decision, in 
writing and specifying the reasons therefor, 
within 30 days after receipt of such request. 
Any such request shall include sufficient infor-
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mation to support the removal of such clinical 
hold. 
‘‘SEC. 587S. COLLABORATIVE COMMUNITIES FOR IN VITRO 
CLINICAL TESTS. 
‘‘(a) IN GENERAL.— 
‘‘(1) For the purposes of facilitating community 
solutions and decision making with respect to in 
vitro clinical tests, the Secretary may participate in 
collaborative communities comprised of public and 
private participants that may provide recommenda-
tions and other advice to the Secretary on the devel-
opment and regulation of in vitro clinical tests. 
‘‘(2) A collaborative community under this sec-
tion shall have broad representation of interested 
private and public-sector stakeholder communities 
and may include patients, care partners, academics, 
health care professionals, health care systems, 
payors, Federal and State agencies, entities respon-
sible for accrediting clinical laboratories, inter-
national regulatory bodies, test developers, or other 
interested entities or communities. 
‘‘(b) GUIDANCE.—The Secretary shall issue a draft 
guidance not later than 180 days after the date of enact-
ment of the Verifying Accurate Leading-edge IVCT Devel-
opment Act of 2021, addressing the participation process 
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and framework to build consensus, and how the Secretary 
may consider, review, and implement recommendations 
under subsection (c). 
‘‘(c) RECOMMENDATIONS.—A collaborative commu-
nity for in vitro clinical tests may make recommendations 
to the Secretary on matters including— 
‘‘(1) mitigating measures for in vitro clinical 
tests; 
‘‘(2) standards development activities and per-
formance standards for in vitro clinical tests or 
groups of such tests; 
‘‘(3) scientific and clinical evidence to support 
new claims for in vitro clinical tests; 
‘‘(4) new technologies and methodologies re-
lated to in vitro clinical tests; 
‘‘(5) stakeholder communication and engage-
ment; and 
‘‘(6) development of effective policies and proc-
esses, including to develop tests, and to regulate 
such tests in accordance with least burdensome re-
quirements described in section 587B(j). 
‘‘(d) USE BY SECRETARY.— 
‘‘(1) IN GENERAL.—The Secretary may adopt 
recommendations made under subsection (b), or oth-
erwise incorporate the feedback from collaborative 
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communities 
into 
regulatory 
decision 
making, 
through rulemaking or guidance, as appropriate. 
‘‘(2) CLARIFICATION.—The Secretary is not re-
quired to adopt recommendations submitted by col-
laborative communities. 
‘‘(e) TRANSPARENCY.—The Secretary shall— 
‘‘(1) publish on the website of the Food and 
Drug Administration matters for which it is seeking 
comments or recommendations, in a timely manner; 
‘‘(2) maintain a list of all collaborative commu-
nities in which the Secretary participates and make 
such list available on the website of the Food and 
Drug Administration; and 
‘‘(3) post on the website of the Food and Drug 
Administration at least once every year a report on 
the recommendations it has adopted and rec-
ommendations it has not adopted from collaborative 
communities. 
‘‘(f) PARTICIPATION.—The Secretary may participate 
in a collaborative community only if such community re-
quires members to disclose conflicts of interest and has 
established a process to address conflicts of interest. 
‘‘(g) EXEMPTION.—The collaborative communities 
established and used in accordance with this section shall 
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be exempt from the Federal Advisory Committee Act (5 
U.S.C. App.). 
‘‘SEC. 587T. COMPREHENSIVE TEST INFORMATION SYSTEM. 
‘‘(a) PURPOSE.—For the purposes of improving the 
transparency of information on in vitro clinical tests and 
allowing patients and health care providers better access 
to information about in vitro clinical tests, the Secretary 
shall establish a comprehensive test information system. 
‘‘(b) ESTABLISHMENT.—Not later than 2 years after 
the date of enactment of the Verifying Accurate Leading- 
edge IVCT Development Act of 2021, the Secretary shall 
make available a comprehensive test information system 
for in vitro clinical tests that is designed to— 
‘‘(1) provide a transparent interface on the 
website of the Food and Drug Administration for 
stakeholders, to the extent permitted by applicable 
law, to access the— 
‘‘(A) regulatory pathway designation infor-
mation for each in vitro clinical test or tests 
with the same indications for use; 
‘‘(B) registration and listing information 
provided by developers under section 587I, in-
cluding the use of a link for labels; 
‘‘(C) adverse event reports submitted 
under section 587L; 
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‘‘(D) reports of corrections and removals 
submitted under section 587M; and 
‘‘(E) other information pertaining to an in 
vitro clinical test or tests with the same indica-
tions for use, as the Secretary determines ap-
propriate; and 
‘‘(2) provide a secure portal for electronic sub-
mission, including applications and other in vitro 
clinical test submissions, registration and listing in-
formation, and adverse event reports. 
‘‘(c) SUBMISSION FUNCTION.—The comprehensive 
test information system shall serve as the electronic sub-
mission service for test developers submitting information 
for applications under sections 587B and 587D. 
‘‘SEC. 587U. PREEMPTION. 
‘‘(a) IN GENERAL.—No State, Tribal, or local gov-
ernment (or political subdivision thereof) may establish or 
continue in effect any requirement related to the develop-
ment, manufacture, labeling, distribution, sale, or use of 
an in vitro clinical test that is different from, or in addi-
tion to, the requirements of this subchapter. 
‘‘(b) EXCEPTIONS.—Subsection (a) shall not be con-
strued to affect the authority of a State, Tribal, or local 
government— 
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‘‘(1) to license laboratory personnel, health care 
practitioners, or health care facilities or to regulate 
any aspect of a health care practitioner-patient rela-
tionship; or 
‘‘(2) to enforce laws of general applicability, 
such as zoning laws, environmental laws, labor laws, 
and general business laws. 
‘‘(c) CLARIFICATION.—This section shall not be con-
strued to shift liability to health care practitioners or other 
users. 
‘‘SEC. 587V. ADULTERATION. 
‘‘An in vitro clinical test shall be deemed to be adul-
terated: 
‘‘(1) If it consists in whole or in part of any 
filthy, putrid, or decomposed substance. 
‘‘(2) If it has been developed, prepared, packed, 
or held under insanitary conditions whereby it may 
have been contaminated with filth, or whereby it 
may have been rendered injurious to health. 
‘‘(3) If its container or package is composed, in 
whole or in part, of any poisonous or deleterious 
substance which may render the contents injurious 
to health. 
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‘‘(4) If it bears or contains, for purposes of 
coloring only, a color additive which is unsafe within 
the meaning of section 721(a). 
‘‘(5) If its analytical or clinical validity, or with 
respect to a specimen receptacle, its safety, or its 
strength, purity, or quality, differs from or falls 
below that which it purports or is represented to 
possess. 
‘‘(6) If it is required to be, declared to be, pur-
ports to be, or is represented as being, in conformity 
with any performance standard established or recog-
nized under section 587Q and is not in all respects 
in conformity with such standard. 
‘‘(7) If it is required to be in conformity with 
a mitigating measure established under section 
587E and is not in all respects in conformity with 
such mitigating measure. 
‘‘(8) If it fails to have an approved premarket 
application under section 587B unless such in vitro 
clinical test can be lawfully offered— 
‘‘(A) for clinical use pursuant to an exemp-
tion under section 587A; 
‘‘(B) for emergency use pursuant to an au-
thorization under section 564; or 
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‘‘(C) for investigational use pursuant to 
section 587R. 
‘‘(9) If it is not in conformity with any condi-
tion established under section 587B, 587D, or 564. 
‘‘(10) If it purports to be an in vitro clinical 
test that is offered for clinical use subject to an ex-
emption under section 587A and it fails to meet or 
maintain any criteria, condition, or requirement of 
such exemption. 
‘‘(11) If it has been granted an exemption 
under section 587R for investigational use, and the 
person granted such exemption or any investigator 
who uses such in vitro clinical test under such ex-
emption fails to comply with a requirement pre-
scribed by or under such section. 
‘‘(12) If it fails to meet the quality require-
ments prescribed in or established under section 
587J (as applicable), or the methods used in, or fa-
cilities or controls used for, its development, manu-
facture, packing, storage, or installation are not in 
conformity with applicable requirements established 
under such section. 
‘‘(13) If it has been developed, manufactured, 
processed, packed or held in any establishment, fac-
tory, or warehouse and the owner, operator or agent 
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of such establishment, factory, or warehouse delays, 
denies, or limits an inspection, or refuses to permit 
entry or inspection. 
‘‘(14) If it is not in compliance with any restric-
tion required under section 587N. 
‘‘SEC. 587W. MISBRANDING. 
‘‘An in vitro clinical test shall be deemed to be mis-
branded: 
‘‘(1) If its labeling is false or misleading in any 
particular. 
‘‘(2) If in a package form unless it bears a label 
containing— 
‘‘(A) the name and place of business of the 
test developer, manufacturer, packer, or dis-
tributor; and 
‘‘(B) an accurate statement of the quantity 
of contents in terms of weight, measure, or nu-
merical count with respect to small packages, 
unless an exemption is granted by the Secretary 
by the issuance of guidance. 
‘‘(3) If any word, statement, or other informa-
tion required by or under authority of this Act to 
appear on the label or labeling, including a test re-
port, is not prominently placed thereon with such 
conspicuousness (as compared with other words, 
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181 
statements, designs, or devices, in the labeling) and 
in such terms as to render it likely to be read and 
understood by the ordinary individual under cus-
tomary conditions of purchase and use. 
‘‘(4) Unless its labeling bears adequate direc-
tions for use and such adequate warnings as are 
necessary for the protection of users of the in vitro 
clinical test and recipients of the results of such in 
vitro clinical test, including patients, consumers, do-
nors, and related health care professionals. Required 
labeling for in vitro clinical tests intended for use in 
health care facilities or by a health care professional 
may be made available solely by electronic means, 
provided that the labeling complies with all applica-
ble requirements of law, and that the test developer, 
manufacturer, or distributor affords such users the 
opportunity to request the labeling in paper form, 
and after such request, promptly provides the re-
quested information without additional cost. 
‘‘(5) If it causes serious or adverse health con-
sequences or death, including through absence, 
delay, or discontinuation in diagnosis or treatment, 
when used in the manner prescribed, recommended, 
or suggested in the labeling thereof. 
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‘‘(6) If it was developed or manufactured in an 
establishment not duly registered under section 587I 
or it was not included in a listing under section 
587I, in accordance with timely reporting require-
ments under this subchapter. 
‘‘(7) In the case of any in vitro clinical test sub-
ject to restrictions under section 587N, (1) if its ad-
vertising is false or misleading in any particular, (2) 
if it is offered for clinical use, sold, distributed, or 
used in violation of such restrictions, or (3) unless 
the test developer, manufacturer, or distributor in-
cludes in all advertisements and other descriptive 
printed matter that such person issues or causes to 
be issued, a brief statement of the intended uses of 
the in vitro clinical test and relevant warnings, pre-
cautions, side effects, and contraindications. This 
subsection shall not be applicable to any printed 
matter that the Secretary determines to be labeling 
as defined in section 201(m) or section 587K. 
‘‘(8) If it was subject to a mitigating measure 
established under section 587E, unless it bears such 
labeling as may be prescribed in such mitigating 
measure. 
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‘‘(9) If it was subject to a standard established 
under section 587Q, unless it bears such labeling as 
may be prescribed in such standard. 
‘‘(10) Unless it bears such labeling as may be 
prescribed by or established under an applicable la-
beling requirement under this Act. 
‘‘(11) If there was a failure or refusal to comply 
with any requirement prescribed under section 587I 
or 587X, or to comply with a requirement under sec-
tion 587Y, or to provide any report, material, or in-
formation required under this subchapter. 
‘‘SEC. 587X. POSTMARKET SURVEILLANCE. 
‘‘(a) IN GENERAL.— 
‘‘(1) IN GENERAL.—In addition to other appli-
cable requirements under this Act, the Secretary 
may issue an order requiring a developer to conduct 
postmarket surveillance of a single in vitro clinical 
test as a condition of approval under section 587B. 
‘‘(2) EXEMPT
TESTS.—The Secretary may 
order postmarket surveillance for tests exempt pur-
suant to section 587A for which the failure of the 
in vitro clinical test to meet the applicable standard 
for approval is likely to result in serious or adverse 
health consequences or death from use of the single 
in vitro clinical test. 
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‘‘(3) CONSIDERATION.—In determining whether 
to require a developer to conduct postmarket surveil-
lance of an in vitro clinical test, the Secretary shall 
take into consideration the benefits and risks for the 
patient and the least burdensome principles under 
section 587B. 
‘‘(b) SURVEILLANCE APPROVAL.— 
‘‘(1) Each developer required to conduct a sur-
veillance of an in vitro clinical test shall submit, 
within 30 days of receiving an order from the Sec-
retary, a plan for the required surveillance. The Sec-
retary, within 60 days of the receipt of such plan, 
shall determine if the person designated to conduct 
the surveillance has the appropriate qualifications 
and experience to undertake such surveillance and if 
the plan will result in useful data that can reveal un-
foreseen adverse events or other information nec-
essary to protect the health of patients or the public. 
‘‘(2) The developer shall commence surveillance 
under this section not later than 15 months after 
the day on which the Secretary orders such postmar-
ket surveillance, unless the Secretary determines 
more time is needed to commence surveillance. 
‘‘(3) The Secretary may order a prospective 
surveillance period of up to 3 years. Any determina-
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tion by the Secretary that a longer period is nec-
essary shall be made by mutual agreement between 
the Secretary and the manufacturer or, if no agree-
ment can be reached, after the completion of a dis-
pute resolution process. 
‘‘SEC. 587Y. ELECTRONIC FORMAT FOR SUBMISSIONS. 
‘‘(a) IN GENERAL.—All presubmissions and submis-
sions to the Food and Drug Administration with respect 
to an in vitro clinical test shall include an electronic copy 
of such presubmission or submission, and, with respect to 
the information required under sections 587B and 587D, 
shall utilize the system described in section 587T. 
‘‘(b) ELECTRONIC FORMAT.—Beginning on such date 
as the Secretary specifies in final guidance issued under 
subsection (c), presubmissions and submissions for in vitro 
clinical tests (and any appeals of action taken by the Sec-
retary with respect to such presubmissions and submis-
sions) shall be submitted solely in such electronic format 
as specified by the Secretary in such guidance. 
‘‘(c) GUIDANCE.—The Secretary shall issue guidance 
implementing this section. In such guidance, the Secretary 
may— 
‘‘(1) provide standards for the electronic copy 
required under subsection (a) or the submission in 
electronic format required under subsection (b); 
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‘‘(2) set forth criteria for waivers of or exemp-
tions from the requirements of subsection (a) or (b); 
and 
‘‘(3) provide any other information for the effi-
cient implementation and enforcement of this sec-
tion. 
‘‘SEC. 587Z. POSTMARKET REMEDIES. 
‘‘(a) SAFETY NOTICE.— 
‘‘(1) IN GENERAL.—If the Secretary determines 
that an in vitro clinical test presents an unreason-
able risk of substantial harm to the public health, 
and notification under this subsection is necessary to 
eliminate the unreasonable risk of such harm and no 
more practicable means is available under the provi-
sions of this Act (other than this section) to elimi-
nate the risk, the Secretary may issue such order as 
may be necessary to ensure that adequate safety no-
tice is provided in an appropriate form, by the per-
sons and means best suited under the circumstances, 
to all health care professionals who prescribe, order, 
or use the in vitro clinical test and to any other per-
son (including developers, manufacturers, importers, 
distributors, retailers, and users) who should prop-
erly receive such notice. 
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‘‘(2) NOTICE
TO
INDIVIDUALS.—An order 
under this subsection shall require that the individ-
uals subject to the risk with respect to which the 
order is to be issued be included in the persons to 
be notified of the risk unless the Secretary deter-
mines that notice to such individuals would present 
a greater danger to the health of such individuals 
than no such notice. If the Secretary makes such a 
determination with respect to such individuals, the 
order shall advise the health care professionals who 
prescribed, ordered, or used the in vitro clinical test 
provide notification to the individuals for whom the 
health professionals prescribed, ordered, or used 
such test, of the risk presented by such in vitro clin-
ical test and of any action which may be taken by 
or on behalf of such individuals to eliminate or re-
duce such risk. Before issuing an order under this 
subsection, the Secretary shall consult with the per-
sons required to give notice under the order. 
‘‘(b) REPAIR, REPLACEMENT, OR REFUND.— 
‘‘(1) DETERMINATION
AFTER
AN
INFORMAL 
HEARING.— 
‘‘(A) IN GENERAL.—If, after affording op-
portunity for an informal hearing, the Secretary 
determines that— 
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‘‘(i) an in vitro clinical test presents 
an unreasonable risk of substantial harm 
to the public health; 
‘‘(ii) there are reasonable grounds to 
believe that the in vitro clinical test was 
not properly developed or manufactured 
considering the state of the art as it ex-
isted at the time of its development or 
manufacture; 
‘‘(iii) there are reasonable grounds to 
believe that the unreasonable risk was not 
caused by failure of a person other than a 
developer, manufacturer, importer, dis-
tributor, or retailer of the in vitro clinical 
test to exercise due care in the installation, 
maintenance, repair, or use of the in vitro 
clinical test; and 
‘‘(iv) the notice authorized by sub-
section (a) would not by itself be sufficient 
to eliminate the unreasonable risk and ac-
tion described in paragraph (2) of this sub-
section is necessary to eliminate such risk, 
the Secretary may order the developer, manu-
facturer, importer, or any distributor of such in 
vitro clinical test, or any combination of such 
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persons, to submit to him within a reasonable 
time a plan for taking one or more of the ac-
tions described in paragraph (2). An order 
issued under the preceding sentence which is di-
rected to more than one person shall specify 
which person may decide which action shall be 
taken under such plan and the person specified 
shall be the person who the Secretary deter-
mines bears the principal, ultimate financial re-
sponsibility for action taken under the plan un-
less the Secretary cannot determine who bears 
such responsibility or the Secretary determines 
that the protection of the public health requires 
that such decision be made by a person (includ-
ing a health professional or user of the in vitro 
clinical test) other than the person the Sec-
retary determines bears such responsibility. 
‘‘(B) SECRETARY APPROVAL OF PLAN.— 
Within 30 calendar days of issuing an order 
under subparagraph (A), the Secretary shall ap-
prove a plan submitted pursuant to an order 
issued under subparagraph (A) unless the Sec-
retary determines (after affording opportunity 
for an informal hearing) that the action or ac-
tions to be taken under the plan or the manner 
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in which such action or actions are to be taken 
under the plan will not assure that the unrea-
sonable risk with respect to which such order 
was issued will be eliminated. If the Secretary 
disapproves a plan, the Secretary shall order a 
revised plan to be submitted within a reason-
able time. If the Secretary determines (after af-
fording opportunity for an informal hearing) 
that the revised plan is unsatisfactory or if no 
revised plan or no initial plan has been sub-
mitted to the Secretary within the prescribed 
time, the Secretary shall (i) prescribe a plan to 
be carried out by the person or persons to 
whom the order issued under subparagraph (A) 
was directed, or (ii) after affording an oppor-
tunity for an informal hearing, by order pre-
scribe a plan to be carried out by a person who 
is a manufacturer, importer, distributor, or re-
tailer of the in vitro clinical test with respect to 
which the order was issued but to whom the 
order under subparagraph (A) was not directed. 
‘‘(2) ACTIONS ON A PLAN.—The actions which 
may be taken under a plan submitted under an 
order issued under paragraph (1) are as follows: 
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‘‘(A) To repair the in vitro clinical test so 
that it does not present the unreasonable risk 
of substantial harm with respect to which the 
order under paragraph (1)(A) was issued. 
‘‘(B) To replace the in vitro clinical test 
with a like or equivalent test which is in con-
formity with all applicable requirements of this 
Act. 
‘‘(C) To refund the purchase price of the 
in vitro clinical test (less a reasonable allowance 
for use if such in vitro clinical test has been in 
the possession of the user for one year or more 
at the time of notice ordered under subsection 
(a), or at the time the user receives actual no-
tice of the unreasonable risk with respect to 
which the order was issued under paragraph 
(1)(A), whichever occurs first). 
‘‘(3) NO CHARGE.—No charge shall be made to 
any person (other than a developer, manufacturer, 
importer, distributor or retailer) for using a remedy 
described in paragraph (2) and provided under an 
order issued under paragraph (1), and the person 
subject to the order shall reimburse each person 
(other than a developer, manufacturer, importer, 
distributor, or retailer) who is entitled to such a 
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remedy for any reasonable and foreseeable expenses 
actually incurred by such person in availing himself 
of such remedy. 
‘‘(c) REIMBURSEMENT.—An order issued under sub-
section (b)(1)(A) with respect to an in vitro clinical test 
may require any person who is a developer, manufacturer, 
importer, distributor, or retailer of the in vitro clinical test 
to reimburse any other person who is a developer, manu-
facturer, importer, distributor, or retailer of such in vitro 
clinical test for such other person’s expenses actually in-
curred in connection with carrying out the order if the 
Secretary determines such reimbursement is required for 
the protection of the public health. Any such requirement 
shall not affect any rights or obligations under any con-
tract to which the person receiving reimbursement or the 
person making such reimbursement is a party. 
‘‘(d) RECALL AUTHORITY.— 
‘‘(1) IN GENERAL.—If the Secretary finds that 
there is a reasonable probability that an in vitro 
clinical test approved under section 587B would 
cause serious, adverse health consequences or death, 
including by the absence, delay, or discontinuation of 
appropriate medical treatment, the Secretary shall 
issue an order requiring the appropriate person (in-
cluding the developers, manufacturers, importers, 
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distributors, or retailers of the in vitro clinical 
test)— 
‘‘(A) to immediately cease distribution of 
such in vitro clinical test; and 
‘‘(B) to immediately notify health profes-
sionals and user facilities of the order and to 
instruct such professionals and facilities to 
cease use of such in vitro clinical test. 
‘‘(2) INFORMAL
HEARING.—The order issued 
under paragraph (1)(A), shall provide the person 
subject to the order with an opportunity for an in-
formal hearing, to be held not later than 10 calendar 
days after the date of the issuance of the order, on 
the actions required by the order and on whether the 
order should be amended to require a recall of such 
in vitro clinical test. If, after providing an oppor-
tunity for such a hearing, the Secretary determines 
that inadequate grounds exist to support the actions 
required by the order, the Secretary shall vacate the 
order. 
‘‘(3) AMENDED ORDER.— 
‘‘(A) IN GENERAL.—If, after providing an 
opportunity for an informal hearing under 
paragraph (2), the Secretary determines that 
the order should be amended to include a recall 
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of the in vitro clinical test with respect to which 
the order was issued, the Secretary shall, except 
as provided in subparagraph (B), amend the 
order to require a recall. The Secretary shall 
specify a timetable in which the recall will occur 
and shall require periodic reports describing the 
progress of the recall. 
‘‘(B) REQUIREMENTS.—An amended order 
under subparagraph (A)— 
‘‘(i) shall not include recall of the in 
vitro clinical test from individuals; 
‘‘(ii) shall not include recall of an in 
vitro clinical test from test user facilities if 
the Secretary determines that the risk of 
recalling such in vitro clinical test from the 
facilities presents a greater health risk 
than the health risk of not recalling the in 
vitro clinical test from use; and 
‘‘(iii) shall provide for notice to indi-
viduals subject to the risks associated with 
the use of such in vitro clinical test. In 
providing the notice required by this 
clause, the Secretary may use the assist-
ance of health professionals who pre-
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scribed, ordered, or used such an in vitro 
clinical test for individuals. 
‘‘(4) CLARIFICATION.—The remedy provided by 
this subsection shall be in addition to remedies pro-
vided by subsections (b) and (c).’’. 
SEC. 4. ENFORCEMENT AND OTHER PROVISIONS. 
(a) PROHIBITED ACTS.—Section 301 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 331) is amend-
ed— 
(1) in paragraphs (a), (b), (c), (g), (k), (q), (r), 
and (y), by inserting ‘‘in vitro clinical test,’’ after 
‘‘device,’’ each place it appears; 
(2) in paragraph (y) by inserting ‘‘or 587P’’ 
after ‘‘section 523’’ each place it appears; and 
(3) by adding at the end, the following: 
‘‘(fff)(1) The introduction or delivery for introduction 
into interstate commerce of an in vitro clinical test in vio-
lation of section 587B(a). 
‘‘(2) The false, fraudulent, or deceptive claiming for 
an in vitro clinical test of an exemption from the pre-
market review required under section 587B. 
‘‘(3) When claiming an exemption under section 
587A from the premarket review required under section 
587B, the failure to maintain complete and accurate docu-
mentation for the exemption as required under section 
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587A or the failure to provide labeling required under sec-
tion 587A. 
‘‘(4) With respect to an in vitro clinical test, the sub-
mission of any report that is required by or under this 
Act that is false or misleading in any material respect. 
‘‘(5) The making of a false, fraudulent, or materially 
deceptive analytical or clinical claim for an in vitro clinical 
test— 
‘‘(A) in any application, report, or notification 
submitted to the Secretary under this Act; or 
‘‘(B) in the labeling or advertising of an in vitro 
clinical test. 
‘‘(6) The failure to comply with a condition of ap-
proval, performance standard, mitigating measure, or re-
striction established in an order approving an application 
or supplement under section 587B; the failure to perform 
a risk analysis required by section 587B; the failure to 
submit an annual report required under section 587B(k); 
or the failure to complete postmarket studies required 
under section 587V. 
‘‘(7) The marketing of an in vitro clinical test in vio-
lation of— 
‘‘(A) an order issued by the Secretary under 
section 587A; or 
‘‘(B) any requirement under section 587A. 
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‘‘(8) With respect to technology certification under 
section 587D, the refusal to permit, or unreasonable delay 
in permitting, an inspection authorized under section 
587D(f)(3)(G); the failure to comply with applicable re-
quirements to submit an application or report under sec-
tion 587D(e); or the failure to comply with applicable 
maintenance requirements under section 587D(h). 
‘‘(9) The failure to comply with an applicable miti-
gating measure established under section 587E or to 
maintain the documentation required under section 
587E(b); or the failure to comply with a performance 
standard established under section 587Q. 
‘‘(10) The failure to register in accordance with sec-
tion 587I, the failure to provide information required 
under section 587I(b), or the failure to maintain or submit 
information required under section 587I(c). 
‘‘(11) The failure to submit a report required under 
section 587L or 587M; the failure to comply with a re-
striction imposed under section 587N; or the failure to 
comply with labeling and advertising requirements under 
section 587N(b). 
‘‘(12) The failure to comply with the requirements 
of section 587P (relating to accredited persons). 
‘‘(13) The failure to comply with any requirement 
prescribed or established under section 587R; the failure 
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to furnish any notification, information, material, or re-
port required under section 587R; or the failure to comply 
with an order issued under section 587R.’’. 
(b) PENALTIES.—Section 303(f)(1) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 333(f)(1)) is 
amended— 
(1) in subparagraph (A), by inserting ‘‘or in 
vitro clinical tests’’ after ‘‘devices’’; and 
(2) in subparagraph (B)(i)— 
(A) by inserting ‘‘, or 587J or 587L,’’ 
after ‘‘520(f)’’; and 
(B) by inserting ‘‘, or who violates section 
587M(b) with respect to a correction report’’ 
after ‘‘risk to public health’’. 
(c) SEIZURE.—Section 304 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 334) is amended— 
(1) in subsection (a)(2)— 
(A) by striking ‘‘and’’ before ‘‘(E) Any’’; 
and 
(B) by inserting ‘‘, and (F) Any adulter-
ated or misbranded in vitro clinical test’’ after 
‘‘tobacco product’’; 
(2) in subsection (d)(1), by inserting ‘‘in vitro 
clinical test,’’ after ‘‘device,’’; and 
(3) in subsection (g)— 
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(A) in paragraph (1), by inserting ‘‘, in 
vitro clinical test,’’ after ‘‘device’’ each place it 
appears; and 
(B) in paragraph (2)— 
(i) in subparagraph (A), by inserting 
‘‘, in vitro clinical test,’’ after ‘‘device’’; 
and 
(ii) in subparagraph (B), by inserting 
‘‘or in vitro clinical test’’ after ‘‘device’’ 
each place it appears. 
(d) DEBARMENT, TEMPORARY
DENIAL
OF
AP-
PROVAL, AND SUSPENSION.—Section 306 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 335a) is 
amended by adding at the end the following: 
‘‘(n) IN VITRO CLINICAL TESTS; MANDATORY DE-
BARMENT REGARDING THIRD-PARTY INSPECTIONS AND 
REVIEWS.— 
‘‘(1) IN GENERAL.—If the Secretary finds that 
a person has been convicted of a felony under sec-
tion 301(gg), 301(fff)(2), 301(fff)(5), or 301(fff)(8), 
the Secretary shall debar such person from being ac-
credited under section 587P and from carrying out 
activities under an agreement described in section 
803(b). 
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‘‘(2) DEBARMENT
PERIOD.—The Secretary 
shall debar a person under paragraph (1) for the fol-
lowing periods: 
‘‘(A) The period of debarment of a person 
(other than an individual) shall not be less than 
1 year or more than 10 years, but if an act 
leading to a subsequent debarment under such 
paragraph occurs within 10 years after such 
person has been debarred under such para-
graph, the period of debarment shall be perma-
nent. 
‘‘(B) The debarment of an individual shall 
be permanent. 
‘‘(3) TERMINATION OF DEBARMENT; JUDICIAL 
REVIEW; OTHER MATTERS.—Subsections (c)(3), (d), 
(e), (i), (j), and (l)(1) apply with respect to a person 
(other than an individual) or an individual who is 
debarred under paragraph (1) to the same extent 
and in the same manner as such subsections apply 
with respect to a person who is debarred under sub-
section (a)(1), or an individual who is debarred 
under subsection (a)(2), respectively.’’. 
(e) JUDICIAL REVIEW.—Section 517(a) of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 360g(a)) 
is amended— 
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(1) in paragraph (8), by striking ‘‘or’’ at the 
end; 
(2) in paragraph (9), by inserting ‘‘or’’ after 
the comma at the end; and 
(3) before the matter that follows paragraph 
(9), by inserting the following: 
‘‘(10) an order issued pursuant to section 
587B, 587D, 587R, or 587S,’’. 
(f) EXPANDED ACCESS TO UNAPPROVED THERAPIES 
AND DIAGNOSTICS.—Section 561 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 360bbb) is amend-
ed— 
(1) in subsections (a) through (d)— 
(A) by striking ‘‘or investigational devices’’ 
each place it appears and inserting ‘‘, investiga-
tional devices, or investigational in vitro clinical 
tests’’; and 
(B) by striking ‘‘or investigational device’’ 
each place it appears (other than the second 
such place in paragraph (3)(A)) and inserting 
‘‘, investigational device, or investigational in 
vitro clinical test’’; 
(2) in subsection (b)(4) by striking ‘‘or 520(g)’’ 
and inserting ‘‘, 520(g), or 587R’’ each place it ap-
pears; 
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(3) in subsection (c)— 
(A) by amending the subsection heading to 
read: ‘‘TREATMENT
INVESTIGATIONAL
NEW 
DRUG APPLICATIONS, TREATMENT INVESTIGA-
TIONAL DEVICE EXEMPTIONS, AND TREAT-
MENT INVESTIGATIONAL
IN VITRO CLINICAL 
TEST EXEMPTIONS’’; 
(B) in paragraph (3)(A), by striking ‘‘or 
investigational device exemption in effect under 
section 520(g)’’ and inserting ‘‘, investigational 
device exemption in effect under section 520(g), 
or investigational in vitro clinical test exemption 
under section 587R’’; 
(C) by striking ‘‘or treatment investiga-
tional device exemption’’ each place it appears 
and inserting ‘‘, treatment investigational device 
exemption, or treatment investigational in vitro 
clinical test exemption’’; and 
(D) in the matter following paragraph (7) 
by striking ‘‘or 520(g)’’ each place it appears 
and inserting ‘‘, 520(g) or 587R’’; and 
(4) by amending subsection (e) to read as fol-
lows: 
‘‘(e) DEFINITIONS.—In this section, the terms ‘inves-
tigational drug’, ‘investigational device’, ‘investigational in 
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