169 
‘‘(B) in the case of changes to clinical pro-
tocols applicable to the test, the changes do not 
affect— 
‘‘(i) the validity of data or information 
resulting from the completion of an ap-
proved clinical protocol; 
‘‘(ii) the scientific soundness of a plan 
submitted under subsection (c)(5); or 
‘‘(iii) the rights, safety, or welfare of 
the human subjects (if any) involved in the 
investigation. 
‘‘(g) CLINICAL HOLD.— 
‘‘(1) IN GENERAL.—At any time, the Secretary 
may impose a clinical hold with respect to an inves-
tigation of an in vitro clinical test if the Secretary 
makes a determination described in paragraph (2). 
The Secretary shall, in imposing such clinical hold, 
specify the basis for the clinical hold, including the 
specific information available to the Secretary which 
served as the basis for such clinical hold, and con-
firm such determination in writing. The applicant or 
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-
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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-
mation to support the removal of such clinical 
hold. 
‘‘SEC. 587S. COLLABORATIVE COMMUNITIES FOR IN VITRO 
CLINICAL TESTS. 
‘‘(a) IN GENERAL.— 
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‘‘(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, 
healthcare professionals, healthcare systems, payers, 
Federal and State agencies, entities responsible for 
accrediting clinical laboratories, international regu-
latory bodies, test developers, or other interested en-
tities 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 2020, addressing the participation process 
and framework to build consensus, and how the Secretary 
may consider, review, and implement recommendations 
under subsection (c). 
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‘‘(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 prin-
cipals under this Act. 
‘‘(d) USE BY SECRETARY.— 
‘‘(1) IN GENERAL.—The Secretary may adopt 
recommendations made under subsection (b), or oth-
erwise incorporate the feedback from collaborative 
communities 
into 
regulatory 
decision 
making, 
through rulemaking or guidance, as appropriate. 
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‘‘(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 internet 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 internet website of the 
Food and Drug Administration; and 
‘‘(3) post on the internet website of the Food 
and Drug Administration at least once every year a 
report on the recommendations it has adopted and 
recommendations it has not adopted from collabo-
rative 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) EXCEPTION.—The Federal Advisory Committee 
Act in the appendix to title 5 shall not apply to collabo-
rative communities established and used in accordance 
with this section. 
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‘‘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 2020, 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 
internet website of the Food and Drug Administra-
tion for stakeholders, to the extent permitted by ap-
plicable 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; 
‘‘(D) reports of corrections and removals 
submitted under section 587M; and 
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‘‘(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 govern-
ment (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— 
‘‘(1) to license laboratory personnel, health care 
practitioners, or health care facilities or to regulate 
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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. 
‘‘(4) If it bears or contains, for purposes of 
coloring only, a color additive which is unsafe within 
the meaning of section 721(a). 
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‘‘(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 
‘‘(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. 
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‘‘(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 
of such establishment, factory, or warehouse delays, 
denies, or limits an inspection, or refuses to permit 
entry or inspection. 
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‘‘(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, 
statements, designs, or devices, in the labeling) and 
in such terms as to render it likely to be read and 
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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. 
‘‘(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 
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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. 
‘‘(9) If it was subject to a standard established 
under section 587Q, unless it bears such labeling as 
may be prescribed in such standard. 
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‘‘(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. 
‘‘(3) CONSIDERATION.—In determining whether 
to require a developer to conduct postmarket surveil-
lance of an in vitro clinical test, the Secretary shall 
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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-
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-
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184 
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); 
‘‘(2) set forth criteria for waivers of or exemp-
tions from the requirements of subsection (a) or (b); 
and 
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185 
‘‘(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. 
‘‘(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 
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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— 
‘‘(i) an in vitro clinical test presents 
an unreasonable risk of substantial harm 
to the public health; 
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‘‘(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 
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 
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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 
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 
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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: 
‘‘(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. 
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‘‘(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 
remedy for any reasonable and foreseeable expenses 
actually incurred by such person in availing himself 
of such remedy. 
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‘‘(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, 
distributors, or retailers of the in vitro clinical 
test)— 
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‘‘(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 
of the in vitro clinical test with respect to which 
the order was issued, the Secretary shall, except 
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‘‘(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 
587A or the failure to provide labeling required under sec-
tion 587A. 
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‘‘(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. 
‘‘(8) With respect to technology certification under 
section 587D, the refusal to permit, or unreasonable delay 
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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 
to furnish any notification, information, material, or re-
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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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202 
vitro clinical test’, ‘treatment investigational new drug ap-
plication’, ‘treatment investigational device exemption’, 
and ‘treatment investigational in vitro clinical test exemp-
tion’ shall have the meanings given the terms in regula-
tions prescribed by the Secretary.’’. 
(g) OPTIMIZING GLOBAL CLINICAL TRIALS.—Section 
569A(b) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 360bbb–8a(b)) is amended by inserting ‘‘an in 
vitro clinical test, as defined in subsection (ss) of such sec-
tion,’’ before ‘‘or a biological product’’. 
(h) PATIENT PARTICIPATION IN MEDICAL PRODUCT 
DISCUSSION.—The heading of subsection (a) of section 
569C of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 360bbb–8c) is amended by striking ‘‘DRUGS AND 
DEVICES’’ and inserting ‘‘DRUGS, DEVICES, AND IN 
VITRO CLINICAL TESTS’’. 
(i) 
REGULATIONS
AND
HEARINGS.—Section 
701(h)(1)(C)(ii) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 371(h)(1)(C)(ii)) is amended by inserting 
‘‘and in vitro clinical tests’’ after ‘‘devices’’. 
(j) FACTORY INSPECTION.—Section 704 of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 374) (other 
than subsection (g)) is amended— 
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(1) by striking ‘‘drugs or devices’’ each place it 
appears and inserting ‘‘drugs, devices, or in vitro 
clinical tests’’; 
(2) in subsection (a)(1), in the third sentence, 
by striking ‘‘or chapter IX’’ and inserting ‘‘section 
587R or chapter IX’’; 
(3) in subsection (a)(2)(B)— 
(A) by inserting ‘‘or in vitro clinical tests’’ 
after ‘‘prescribe or use devices’’; and 
(B) by inserting ‘‘or in vitro clinical tests’’ 
after ‘‘process devices’’; 
(4) by inserting ‘‘in vitro clinical test,’’ after 
‘‘device,’’ each place it appears; 
(5) after making the amendments in para-
graphs (1) and (2), by inserting ‘‘in vitro clinical 
tests,’’ after ‘‘devices,’’ each place it appears; 
(6) in subsection (e), by inserting ‘‘, or section 
587L, 587M, or 587R,’’ after ‘‘section 519 or 
520(g)’’; and 
(7) in subsection (f)(3)— 
(A) in subparagraph (A), by striking ‘‘or’’ 
at the end; 
(B) in subparagraph (B), by striking the 
period at the end and inserting ‘‘; or’’; and 
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204 
(C) after subparagraph (B), by inserting 
the following: 
‘‘(C) is accredited under section 587P.’’. 
(k) PUBLICITY.—Section 705(b) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 375(b)) is amended 
by inserting ‘‘in vitro clinical tests,’’ after ‘‘devices,’’. 
(l) PRESUMPTION.—Section 709 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 379a) is amended by 
inserting ‘‘in vitro clinical test,’’ after ‘‘device,’’. 
(m) IMPORTS AND EXPORTS.—Section 801 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 381) 
is amended— 
(1) in subsection (a)— 
(A) by inserting ‘‘in vitro clinical tests,’’ 
after ‘‘devices,’’ each place it appears; and 
(B) by inserting ‘‘in the case of an in vitro 
clinical test, the test does not conform to the 
applicable requirements of section 587J, or’’ 
after ‘‘requirements of section 520(f), or’’; 
(2) in subsection (d)(3)— 
(A) in subparagraph (A)— 
(i) in the matter preceding clause (i), 
by inserting ‘‘and no component of an in 
vitro clinical test or other article of in vitro 
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205 
clinical test that requires further proc-
essing,’’ after ‘‘health-related purposes’’; 
(ii) in clause (i), by striking ‘‘drug or 
device’’ and inserting ‘‘drug, device, or in 
vitro clinical test’’; and 
(iii) in clause (i)(I), by inserting ‘‘in 
vitro clinical test,’’ after ‘‘device,’’; and 
(B) in subparagraph (B), by inserting ‘‘in 
vitro clinical test,’’ after ‘‘device,’’; and 
(3) in subsection (e)(1), by inserting ‘‘in vitro 
clinical test,’’ after ‘‘device,’’. 
(n) OFFICE OF INTERNATIONAL RELATIONS.—Sec-
tion 803 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 383) is amended— 
(1) in subsection (b)— 
(A) in the matter preceding paragraph (1), 
by inserting ‘‘and in vitro clinical tests’’ after 
‘‘devices’’; and 
(B) in paragraph (1), by inserting ‘‘quality 
requirements established under section 587J; 
and’’ at the end; and 
(2) in subsection (c)— 
(A) in paragraph (2), by inserting ‘‘in vitro 
clinical tests,’’ after ‘‘devices,’’; and 
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(B) in paragraph (4), by inserting ‘‘or in 
vitro clinical tests’’ after ‘‘devices’’. 
(o) RECOGNITION OF FOREIGN GOVERNMENT IN-
SPECTIONS.—Section 809(a)(1) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 384e(a)(1)) is amend-
ed by inserting ‘‘, or section 587I’’ after ‘‘510(h)’’. 
(p) FOOD
AND DRUG ADMINISTRATION.—Section 
1003(b)(2) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 393(b)(2)) is amended— 
(1) in subparagraph (D), by striking ‘‘and’’ at 
the end; 
(2) in subparagraph (E), by striking the semi-
colon at the end and inserting ‘‘; and’’; and 
(3) by adding at the end the following: 
‘‘(F) in vitro clinical tests are analytically 
and clinically valid;’’. 
(q) OFFICE OF WOMEN’S HEALTH.—Section 1011(b) 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
399b(b)) is amended— 
(1) in paragraph (1), by inserting ‘‘in vitro clin-
ical tests,’’ after ‘‘devices,’’; and 
(2) in paragraph (4), by striking ‘‘and device 
manufacturers’’ and inserting ‘‘device manufactur-
ers, and in vitro clinical test developers,’’. 
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(r) 
COUNTERMEASURE
PROVISIONS
OF
THE 
PHSA.—Title III of the PHSA is amended— 
(1) in section 319F–2(c)(1)(B) (42 U.S.C. 
247d–6b(c)(1)(B)) is amended— 
(A) by striking ‘‘or device’’ and inserting 
‘‘device’’; and 
(B) by inserting ‘‘or an in vitro clinical 
test (as that term is defined in section 201(ss) 
of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 321(ss)))’’ after ‘‘Act (21 U.S.C. 
321(h)))’’; 
(2) in section 319F–1(a)(2) (42 U.S.C. 247d– 
6a(a)(2)), by inserting ‘‘an in vitro clinical tests (as 
that term is defined in section 201(ss) of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 
321(ss))),’’ before ‘‘or device’’; and 
(3) in section 319F–3(i)(7) (42 U.S.C. 247d– 
6d(i)(7)), by inserting ‘‘an in vitro clinical tests (as 
that term is defined in section 201(ss) of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 
321(ss))),’’ before ‘‘or device’’. 
SEC. 5. TRANSITION. 
(a) IMPLEMENTATION.— 
(1) IN
GENERAL.—Except as otherwise pro-
vided in this section, the amendments made by this 
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Act apply beginning on the first day of the fourth 
fiscal year that begins after the date of enactment 
of this Act (in this section and in subchapter J of 
chapter V of the Federal Food, Drug, and Cosmetic 
Act, as added by this Act, referred to in this section 
as the ‘‘effective date of this Act’’), except that the 
Secretary of Health and Human Services (in this 
section referred to as the ‘‘Secretary’’) may take the 
actions described in paragraph (2) as described in 
such paragraph, and may take such other actions, 
and expend such funds, as the Secretary determines 
necessary to ensure an orderly transition. 
(2) ACTIONS.—The Secretary shall, prior to the 
date on which the amendments made by this Act 
generally apply pursuant to paragraph (1)— 
(A) within 2 years of the date of enact-
ment of this Act hold the public meetings de-
scribed in subchapter J of chapter V of the 
Federal Food, Drug, and Cosmetic Act, as 
added by section 3; 
(B) within 2 years of the date of enact-
ment of this Act promulgate regulations re-
quired under sections 587L, 587M, 587V, and 
587W; 
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(C) issue final guidance on premarket re-
view requirements under section 587B, tech-
nology certification review requirements under 
section 587D, and applicability under section 
587A; and 
(D) promulgate additional regulations re-
quired by such amendments made by this Act. 
(3) APPLICABILITY
OF
REGULATIONS.—Not-
withstanding the date on which guidance or regula-
tions are issued under paragraph (2), no guidance or 
regulations issued pursuant to the amendments 
made by this Act shall take effect until the effective 
date of this Act, as described in paragraph (1), ex-
cept as otherwise provided for transitional tests. 
(b) APPLICATION
OF AUTHORITIES
TO IN VITRO 
CLINICAL TESTS UNTIL AND AFTER EFFECTIVE DATE 
OF THIS ACT.—Except as provided in subsection (d), for 
any product or test that is an in vitro clinical test as de-
fined in section 201(ss) of the Federal Food, Drug, and 
Cosmetic Act, as added by this Act, the following authori-
ties shall apply: 
(1) TESTS OFFERED PRIOR TO ENACTMENT.— 
An in vitro clinical test that meets the criteria for 
a grandfathered test as set forth in section 
587A(c)(2) of the Federal Food, Drug, and Cos-
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metic Act, as added by section 3, may continue to 
be offered for clinical use and shall be subject only 
to applicable provisions of section 353 of the Public 
Health Service Act and section 587A(a)(4) of the 
Federal Food, Drug, and Cosmetic Act, as added by 
section 3. 
(2) TESTS OFFERED ON OR AFTER ENACTMENT 
BUT BEFORE IMPLEMENTATION.—Before any prod-
uct or test that is an in vitro clinical test as defined 
in section 201(ss) of the Federal Food, Drug, and 
Cosmetic Act, as added by this Act, is first offered, 
sold, or distributed after the date of enactment of 
this Act, but prior to 90 days before the effective 
date of this Act, such product or test shall be con-
sidered a transitional test as described under sub-
section (d) and comply with the applicable device 
provisions of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 301 et seq.) and the Public Health 
Service Act (42 U.S.C. 201 et seq.). 
(3) TESTS UNDER REVIEW BEGINNING ON OR 
AFTER THE DATE OF ENACTMENT OF THIS ACT BUT 
PRIOR TO IMPLEMENTATION.—For any product or 
test that is an in vitro clinical test as defined in sec-
tion 201(ss) of the Federal Food, Drug, and Cos-
metic Act, as added by this Act, for which a submis-
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sion for marketing authorization under section 515, 
clearance under section 510(k), authorization under 
section 513(f)(2), approval under section 520(m), or 
emergency use authorization under section 564 of 
the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 360e, 360(k), 360c(f)(2), 360j(m), 360bbb– 
3) or approval under the Public Health Service Act 
(42 U.S.C. 201 et seq.) is pending on the effective 
date of this Act, the Secretary may review and take 
action on such submission after the effective date of 
this Act according to the statutory provision under 
which such submission was submitted. 
(c) APPLICATION
OF
AUTHORITIES
TO
TRANSI-
TIONAL
AND
GRANDFATHERED
IN
VITRO
CLINICAL 
TESTS.— 
(1) DEFINITION.—For purposes of this para-
graph, the term ‘‘transitional in vitro clinical test’’ 
means an in vitro clinical test, as defined in section 
201(ss) of the Federal Food, Drug, and Cosmetic 
Act, as added by this Act, that— 
(A) was developed by a clinical laboratory 
certified by the Secretary under section 353 of 
the Public Health Service Act (42 U.S.C. 263a) 
that meets the requirements for performing 
high-complexity testing for use only within that 
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certified laboratory or another laboratory within 
the organization under common ownership; 
(B) does not have an approval under sec-
tion 515, a clearance under section 510(k), an 
authorization under section 513(f)(2), an ap-
proval under section 520(m), or an emergency 
use authorization under section 564 of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 
360e, 360(k), 360c(f)(2), 360j(m), 360bbb–3) 
or approval under the Public Health Service 
Act (42 U.S.C. 201 et seq.); and 
(C) is first offered for clinical use during 
the period beginning on the date of enactment 
of this Act and ending on the implementation 
date of this Act. 
(2) CONTINUED
OFFERING.—Notwithstanding 
subsection (c), a transitional in vitro clinical test 
may continue to be offered for clinical use until the 
effective date of this Act, as described in subsection 
(b)(1), except that the Secretary retains authority to 
enforce the device provisions of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) and 
the Public Health Service Act (42 U.S.C. 201 et 
seq.) for any specific transitional in vitro clinical 
test, or any type of transitional in vitro clinical test, 
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as the Secretary determines necessary to protect the 
public from a serious risk to health. 
(3) PREMARKET REVIEW OR TECHNOLOGY CER-
TIFICATION.—A transitional in vitro clinical test 
that is the subject of an application for premarket 
review under section 587B of the Federal Food, 
Drug, and Cosmetic Act or technology certification 
application under section 587D of such Act, as 
added by this Act, that is submitted within 90 days 
of the effective date of this Act may continue to be 
offered, sold, or distributed until completion of the 
Secretary’s review of the premarket application or 
technology certification application. 
(d) CONVERSION.— 
(1) DEEMED PREMARKET APPROVAL.—Any in 
vitro clinical test (as defined in section 201(ss) of 
the Federal Food, Drug, and Cosmetic Act, as 
added by this Act) with a premarket approval under 
section 515, a clearance under section 510(k), an 
authorization under section 513(f), or a licensure 
under section 351 of the Public Health Service Act 
(42 U.S.C. 262) is deemed to have an approved ap-
plication under section 587B of the Federal Food, 
Drug, and Cosmetic Act, as added by this Act, be-
ginning on the later of— 
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(A) the effective date of this Act; or 
(B) such other date, not later than 3 years 
after such effective date, as the person respon-
sible for the device selects. 
(2) 
DEEMED
INVESTIGATIONAL
USE
AP-
PROVAL.—Any in vitro clinical test (as defined in 
section 201(ss) of the Federal Food, Drug, and Cos-
metic Act, as added by this Act) that has an ap-
proved investigational device exemption under sec-
tion 520(g) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 360j(g)) is deemed to have an 
approved investigational use under section 587Q of 
such Act, as added by this Act, beginning on the ef-
fective date of this Act. 
(e) INSTRUMENTS.—An instrument (as defined in 
section 587 of the Federal Food, Drug, and Cosmetic Act, 
as added by this Act) that was purchased prior to the date 
of enactment of this Act and was not cleared, authorized, 
or approved by the Food and Drug Administration or part 
of an instrument family that was cleared, authorized, or 
approved by the Food and Drug Administration at the 
time of purchase may continue to be used by the purchaser 
to develop and introduce into interstate commerce an in 
vitro clinical test during the period beginning on the date 
of enactment of this Act and ending 5 years after such 
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date of enactment. Beginning at the end of such period, 
any new in vitro clinical test that is developed and intro-
duced into interstate commerce shall be based on an in-
strument (as defined in section 587(11) of the Federal 
Food, Drug, and Cosmetic Act, as added by section 3) 
that complies with the requirements of the Federal Food, 
Drug, and Cosmetic Act, as amended by this Act. 
(f) RELATION TO IN VITRO CLINICAL TEST PROVI-
SION.—This section applies notwithstanding section 
587A(a)(1)(C) of the Federal Food, Drug, and Cosmetic 
Act, as added by this Act. 
SEC. 6. EMERGENCY USE AUTHORIZATION. 
Section 564 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 360bbb–3) is amended— 
(1) in paragraphs (1) and (4)(C) of subsection 
(a), by inserting ‘‘in vitro clinical test,’’ before ‘‘or 
biological product’’ each place such term appears; 
and 
(2) in subsection (e)(3)— 
(A) in subparagraph (B), by striking 
‘‘and’’ at the end; 
(B) in subparagraph (C), by striking the 
period and inserting ‘‘; and’’; and 
(C) by adding at the end the following: 
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‘‘(D) quality system requirements (with re-
spect to in vitro clinical tests) under section 
587J.’’. 
SEC. 7. ANTIMICROBIAL SUSCEPTIBILITY TESTS. 
Section 511A of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 360a–2) is amended— 
(1) in subsection (a)(1)(C)— 
(A) by striking ‘‘or approve under section 
515’’ and inserting ‘‘approve under section 515, 
or approve, exempt, or issue a technology cer-
tification order under subchapter J’’; and 
(B) by striking ‘‘testing devices’’ and in-
serting ‘‘tests’’; 
(2) in subsection (c)(5), by striking ‘‘drug or 
device’’ each place it appears and inserting ‘‘drug, 
device, or in vitro clinical test’’; 
(3) in subsection (e)— 
(A) in the heading, by striking ‘‘TESTING 
DEVICES’’ and inserting ‘‘IN VITRO CLINICAL 
TESTS’’; 
(B) in paragraph (1)— 
(i) by striking ‘‘and 515,’’ and insert-
ing ‘‘515, 587B, and 587D’’; 
(ii) by striking ‘‘antimicrobial suscep-
tibility testing device’’ and inserting ‘‘anti-
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217 
microbial susceptibility in vitro clinical 
test’’; and 
(iii) by striking ‘‘such device’’ and in-
serting ‘‘such test’’; 
(C) in paragraph (2)— 
(i) in the heading, by striking ‘‘TEST-
ING
DEVICES’’ and inserting ‘‘IN
VITRO 
CLINICAL TESTS’’; and 
(ii) by amending subparagraph (C) to 
read as follows: 
‘‘(C) The antimicrobial susceptibility in 
vitro clinical test meets all other requirements 
to be approved under section 587B or exempted 
from premarket review under section 587D.’’; 
and 
(D) after making the amendments in sub-
paragraphs (B)(ii), (B)(iii), and (C)(ii), by 
striking ‘‘device’’ each place it appears and in-
serting ‘‘in vitro clinical test’’; 
(4) in subsection (f), by amending paragraph 
(1) to read as follows: 
‘‘(1) The term ‘antimicrobial susceptibility in 
vitro clinical test’ means an in vitro clinical test that 
utilizes susceptibility test interpretive criteria to de-
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218 
termine and report the in vitro susceptibility of cer-
tain microorganisms to a drug (or drugs).’’; and 
(5) in subsection (g)(2)— 
(A) by amending the matter preceding sub-
paragraph (A) to read as follows: 
‘‘(2) with respect to clearing under section 
510(k), classifying under section 513(f)(2), approv-
ing under section 515 or section 587B, or exempting 
from approval requirements under section 587D—’’; 
and 
(B) in subparagraph (A)— 
(i) by striking ‘‘device’’ and inserting 
‘‘in vitro clinical test’’; and 
(ii) by striking ‘‘antimicrobial suscep-
tibility testing device’’ and inserting ‘‘anti-
microbial susceptibility in vitro clinical 
test’’. 
SEC. 8. COMBINATION PRODUCTS. 
(a) IN GENERAL.—Section 503(g) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 353(g)) is 
amended— 
(1) in paragraph (1)— 
(A) in subparagraph (A)— 
(i) by inserting ‘‘(except for a com-
bination product constituted of a device 
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219 
and an in vitro clinical test)’’ after ‘‘agency 
center,’’; and 
(ii) by inserting ‘‘in vitro clinical 
test,’’ before ‘‘or biological product’’; and 
(B) in subparagraph (D)— 
(i) in the matter preceding clause (i), 
by striking ‘‘. If the Secretary determines’’ 
and inserting ‘‘, except for a combination 
product constituted of a device and an in 
vitro clinical test. For other combination 
products, if the Secretary determines’’; and 
(ii) in clause (ii)— 
(I) by inserting ‘‘or in vitro clin-
ical test’’ after ‘‘device’’; and 
(II) by inserting ‘‘and in vitro 
clinical tests’’ before ‘‘shall’’; 
(2) in paragraph (3), by striking ‘‘safety and 
effectiveness or substantial equivalence’’ and insert-
ing ‘‘safety and effectiveness, substantial equiva-
lence, or analytical validity and clinical validity’’ be-
fore ‘‘for the approved constituent part’’; 
(3) in paragraph (4)— 
(A) in subparagraph (A), by striking ‘‘or 
513(f)(2) (submitted in accordance with para-
graph (5))’’ and inserting ‘‘513(f)(2) (sub-
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mitted in accordance with paragraph (5)), 
587B, or an exempt test under section 587A, as 
applicable’’; and 
(B) in subparagraph (B), by inserting ‘‘or 
587B’’ after ‘‘section 515’’; 
(4) in paragraph (5)(A), by striking ‘‘or 
510(k)’’ and inserting ‘‘, 510(k), or 587B’’; 
(5) in paragraph (7), by striking ‘‘or substan-
tial equivalence’’ and inserting ‘‘, substantial equiva-
lence, or analytical validity and clinical validity’’; 
(6) in paragraph (8), by adding at the end the 
following: 
‘‘(I) This paragraph shall not apply to a 
combination product constituted of a device and 
an in vitro clinical test.’’; and 
(7) in paragraph (9)— 
(A) in subparagraph (C)(i), by striking ‘‘or 
520(g)’’ and inserting ‘‘520(g), or 587B’’; and 
(B) in subparagraph (D), by striking ‘‘or 
520’’ and inserting ‘‘520, or 587B’’. 
(b) CLASSIFICATION OF PRODUCTS.—Section 563 of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360bbb–2) is amended by adding at the end the following: 
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‘‘(d) EXEMPTION.—This section shall not apply to a 
combination product constituted of a device and an in 
vitro clinical test.’’. 
SEC. 9. RESOURCES. 
(a) FINDINGS.—Congress finds that the fees author-
ized by this section will be dedicated to meeting the goals 
identified in the letters from the Secretary of Health and 
Human Services to the Committee on Health, Education, 
Labor, and Pensions of the Senate and the Committee on 
Energy and Commerce of the House of Representatives, 
as set forth in the Congressional Record. 
(b) ESTABLISHMENT OF USER FEE PROGRAM.— 
(1) DEVELOPMENT
OF
USER
FEES
FOR
IN 
VITRO CLINICAL TESTS.— 
(A) IN
GENERAL.—Beginning not later 
than October 1, 2020, the Secretary of Health 
and Human Services (in this section referred to 
as the ‘‘Secretary’’) shall develop recommenda-
tions to present to Congress with respect to the 
goals, and plans for meeting the goals, for the 
process of the review of in vitro clinical test ap-
plications submitted under subchapter J of 
chapter V of the Federal Food, Drug, and Cos-
metic Act, as added by this Act, for the first 5 
fiscal years after fiscal year 2021. In developing 
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such recommendations, the Secretary shall con-
sult with— 
(i) the Committee on Energy and 
Commerce of the House of Representa-
tives; 
(ii) the Committee on Health, Edu-
cation, Labor, and Pensions of the Senate; 
(iii) scientific and academic experts; 
(iv) health care professionals; 
(v) representatives of patient and con-
sumer advocacy groups; and 
(vi) the regulated industry. 
(B) PRIOR PUBLIC INPUT.—Prior to begin-
ning negotiations with the regulated industry 
on the authorization of such subchapter J, the 
Secretary shall— 
(i) publish a notice in the Federal 
Register requesting public input on the au-
thorization of user fees; 
(ii) hold a public meeting at which the 
public may present its views on the author-
ization, including specific suggestions for 
the recommendations submitted under sub-
paragraph (E); 
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(iii) provide a period of 30 days after 
the public meeting to obtain written com-
ments from the public suggesting changes 
to such subchapter J; and 
(iv) publish any comments received 
under clause (iii) on the internet website of 
the Food and Drug Administration. 
(C) PERIODIC
CONSULTATION.—Not less 
frequently than once every month during nego-
tiations with the regulated industry, the Sec-
retary shall hold discussions with representa-
tives of patient and consumer advocacy groups 
to continue discussions of the authorization 
under such subchapter J and to solicit sugges-
tions to be included in the recommendations 
transmitted to Congress under subparagraph 
(E). 
(D) PUBLIC
REVIEW
OF
RECOMMENDA-
TIONS.—After negotiations with the regulated 
industry, the Secretary shall— 
(i) present the recommendations de-
veloped under subparagraph (A) to the 
Committee on Health, Education, Labor, 
and Pensions of the Senate and the Com-
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224 
mittee on Energy and Commerce of the 
House of Representatives; 
(ii) publish such recommendations in 
the Federal Register; 
(iii) provide for a period of 30 days 
for the public to provide written comments 
on such recommendations; 
(iv) hold a meeting at which the pub-
lic may present its views on such rec-
ommendations; and 
(v) after consideration of such public 
views and comments, revise such rec-
ommendations as necessary. 
(E) 
TRANSMITTAL
OF
RECOMMENDA-
TIONS.— 
(i) IN
GENERAL.—Not later than 
June 1, 2021, the Secretary shall transmit 
to Congress the revised recommendations 
under subparagraph (A), a summary of the 
views and comments received under such 
subparagraph, and any changes made to 
the recommendations in response to such 
views and comments. 
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(ii) 
RECOMMENDATION
REQUIRE-
MENTS.—The 
recommendations 
trans-
mitted under this subparagraph shall— 
(I) include the number of full- 
time equivalent employees per fiscal 
year that are agreed to be hired to 
carry out the goals included in such 
recommendations for each year of the 
5-year period; 
(II) provide that the amount of 
operating reserve balance in the user 
fee program established under this 
section is not more than the equiva-
lent of 10 weeks of operating reserve; 
(III) require the development of 
a strategic plan for any surplus within 
the operating reserve account above 
the 10-week operating reserve within 
2 years of the establishment of the 
program; 
(IV) include an operating reserve 
adjustment such that, if the Secretary 
has an operating reserve balance in 
excess of 10 weeks of such operating 
reserves, the Secretary shall decrease 
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such fee revenue and fees to provide 
for not more than 10 weeks of such 
operating reserves; 
(V) if an adjustment is made as 
described in subclause (IV), provide 
the rationale for the amount of the 
decrease in fee revenue and fees shall 
be contained in the Federal Register; 
and 
(VI) provide that the fees as-
sessed and collected for the full-time 
equivalent employees at the Center for 
Devices and Radiological Health, with 
respect to which the majority of time 
reporting data indicates are dedicated 
to the review of in vitro clinical tests, 
are not supported by the funds au-
thorized to be collected and assessed 
under section 738 of the Federal 
Food, Drug, and Cosmetic Act (21 
U.S.C. 379j). 
(F) 
PUBLICATION
OF
RECOMMENDA-
TIONS.—The Secretary shall publish on the 
internet website of the Food and Drug Admin-
istration the revised recommendations under 
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subparagraph (A), a summary of the views and 
comments received under subparagraphs (B) 
through (D), and any changes made to the rec-
ommendations originally proposed by the Sec-
retary in response to such views and comments. 
(G) MINUTES
OF
NEGOTIATION
MEET-
INGS.— 
(i) 
PUBLIC
AVAILABILITY.—Before 
transmitting the recommendations devel-
oped under subparagraphs (A) through (F) 
to Congress, the Secretary shall make pub-
licly available, on the internet website of 
the Food and Drug Administration, min-
utes of all negotiation meetings conducted 
under this subsection between the Food 
and Drug Administration and the regu-
lated industry. 
(ii) 
CONTENT.—The 
minutes 
de-
scribed under clause (i) shall summarize 
any substantive proposal made by any 
party to the negotiations, any significant 
controversies or differences of opinion dur-
ing the negotiations, and the resolution of 
any such controversy or difference of opin-
ion. 
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228 
(2) ESTABLISHMENT
OF
USER
FEE
PRO-
GRAM.—Effective on October 1, 2021, provided that 
the Secretary transmits the recommendations under 
paragraph (1)(E), the Secretary is authorized to col-
lect user fees relating to the submission of in vitro 
clinical test applications submitted under subchapter 
J of chapter V of the Federal Food, Drug, and Cos-
metic Act, as added by this Act. Fees under such 
program shall be assessed and collected only if the 
requirements under paragraph (4) are met. 
(3) AUDIT.— 
(A) IN GENERAL.—On the date that is 2 
years after first receiving a user fee applicable 
to submission of an in vitro clinical test applica-
tion submitted under subchapter J of chapter V 
of the Federal Food, Drug, and Cosmetic Act, 
as added by this Act, and on a biennial basis 
thereafter until October 1, 2027, the Secretary 
shall perform an audit of the costs of reviewing 
such applications under such subchapter J. 
Such an audit shall compare the costs of re-
viewing such applications under such sub-
chapter J to the amount of the user fee applica-
ble to such applications. 
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229 
(B) ALTERATION OF USER FEE.—If the 
audit performed under subparagraph (A) indi-
cates that the user fees applicable to applica-
tions submitted under such subchapter J exceed 
30 percent of the costs of reviewing such appli-
cations, the Secretary shall alter the user fees 
applicable to applications submitted under such 
subchapter J such that the user fees do not ex-
ceed such percentage. 
(C) ACCOUNTING STANDARDS.—The Sec-
retary shall perform an audit under subpara-
graph (A) in conformance with the accounting 
principles, standards, and requirements pre-
scribed by the Comptroller General of the 
United States under section 3511 of title 31, 
United States Code, to ensure the validity of 
any potential variability. 
(4) CONDITIONS.—The user fee program de-
scribed in this subsection shall take effect only if the 
Food and Drug Administration issues draft guidance 
related to the review requirements for in vitro diag-
nostic tests that would be subject to premarket re-
view under section 587B of the Federal Food, Drug, 
and Cosmetic Act, as added by section 3, the review 
requirements for test categories eligible for tech-
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nology certification under section 587D of such Act, 
as added by section 3, and the parameters for the 
test categories that would be exempt from any re-
view under subchapter J of chapter V of such Act. 
(5) USER FEE PROGRAM DEFINITIONS AND RE-
SOURCE REQUIREMENTS.— 
(A) IN GENERAL.—The term ‘‘process for 
the review of in vitro clinical test applications’’ 
means the following activities of the Secretary 
with respect to the review of premarket applica-
tions under section 587B of the Federal Food, 
Drug, and Cosmetic Act (as added by section 
3), technology certification applications under 
section 587D of such Act (as added by section 
3), and supplements for such applications: 
(i) The activities necessary for the re-
view of premarket applications, premarket 
reports, and supplements to such applica-
tions. 
(ii) The issuance of action letters that 
allow the marketing of in vitro clinical 
tests or which set forth in detail the spe-
cific deficiencies in such applications, re-
ports, supplements, or submissions and, 
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where appropriate, the actions necessary to 
place them in condition for approval. 
(iii) The inspection of manufacturing 
establishments and other facilities under-
taken as part of the Secretary’s review of 
pending premarket applications, technology 
certifications, and supplements. 
(iv) Monitoring of research conducted 
in connection with the review of such appli-
cations, supplements, and submissions. 
(v) Review of in vitro clinical test ap-
plications subject to section 351 of the 
Public Health Service Act (42 U.S.C. 
262), investigational new drug applications 
under section 505(i) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 
355(i)), or investigational test exemptions 
under section 587A(m) of the Federal 
Food, Drug, and Cosmetic Act (as added 
by section 3), and activities conducted in 
anticipation of the submission of such ap-
plications under section 505(i) of the Fed-
eral Food, Drug, and Cosmetic Act or in-
vestigational use under section 587R of the 
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Federal Food, Drug, and Cosmetic Act (as 
added by section 3). 
(vi) The development of guidance, pol-
icy documents, or regulations to improve 
the process for the review of premarket ap-
plications, technology certification applica-
tions, and supplements. 
(vii) The development of voluntary 
test methods, consensus standards, or 
mandatory performance standards in con-
nection with the review of such applica-
tions, supplements, or submissions and re-
lated activities. 
(viii) The provision of technical assist-
ance to in vitro clinical test developers in 
connection with the submission of such ap-
plications, reports, supplements, or submis-
sions. 
(ix) Any activity undertaken in con-
nection with the initial classification or re-
classification of an in vitro clinical test in 
connection with any requirement for ap-
proval of an in vitro clinical test. 
(x) Evaluation of postmarket studies 
required as a condition of an approval of 
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a premarket application of an in vitro clin-
ical test. 
(xi) Compiling, developing, and re-
viewing information on relevant in vitro 
clinical tests to identify issues with the ap-
plicable standard for premarket applica-
tions, technology certification applications, 
and supplements. 
(B) RESOURCE REQUIREMENTS.—Fees col-
lected and assessed under this section shall be 
used for the process for the review of in vitro 
clinical test applications, as described in sub-
paragraph (A), and shall— 
(i) be subject to the limitation under 
section 738(g)(3) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 
379j(g)(3)), in the same manner that fees 
collected 
and 
assessed 
under 
section 
737(9)(C) 
of 
such 
Act 
(21 
U.S.C. 
379i(9)(C)) are subject to such limitation; 
(ii) include travel expenses for officers 
and employees of the Food and Drug Ad-
ministration only if the Secretary deter-
mines that such travel is directly related to 
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234 
an activity described in subparagraph (A); 
and 
(iii) not be allocated to purposes de-
scribed under section 722(a) of the Con-
solidated Appropriations Act, 2018 (Public 
Law 115–141). 
(c) REPORTS.— 
(1) PERFORMANCE REPORT.— 
(A) IN GENERAL.— 
(i) GENERAL
REQUIREMENTS.—Be-
ginning with fiscal year 2021, for each fis-
cal year for which fees are collected under 
this section, the Secretary shall prepare 
and submit to the Committee on Health, 
Education, Labor, and Pensions of the 
Senate and the Committee on Energy and 
Commerce of the House of Representatives 
annual reports concerning the progress of 
the Food and Drug Administration in 
achieving the goals identified in the rec-
ommendations transmitted to Congress by 
the Secretary pursuant to subsection 
(b)(1)(E) during such fiscal year and the 
future plans of the Food and Drug Admin-
istration for meeting the goals. 
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(ii) ADDITIONAL INFORMATION.—Be-
ginning with fiscal year 2021, the annual 
report under this subparagraph shall in-
clude the progress of the Food and Drug 
Administration in achieving the goals, and 
future plans for meeting the goals, includ-
ing— 
(I) the number of premarket ap-
plications filed under section 587B of 
the Federal Food, Drug, and Cos-
metic Act during the applicable fiscal 
year; 
(II) the number of technology 
certification 
applications 
submitted 
under section 587D of the Federal 
Food, Drug, and Cosmetic Act during 
the applicable fiscal year for each re-
view division; and 
(III) the number of breakthrough 
designations under section 587C of 
the Federal Food, Drug, and Cos-
metic Act during the applicable fiscal 
year. 
(iii) REAL-TIME REPORTING.— 
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(I) IN GENERAL.—Not later than 
30 calendar days after the end of the 
second quarter of fiscal year 2021, 
and not later than 30 calendar days 
after the end of each quarter of each 
fiscal year thereafter, the Secretary 
shall post the data described in sub-
clause (II) on the internet website of 
the Food and Drug Administration 
for such quarter and on a cumulative 
basis for such fiscal year, and may re-
move duplicative data from the annual 
report under this subparagraph. 
(II) DATA.—The Secretary shall 
post the following data in accordance 
with subclause (I): 
(aa) The number and titles 
of draft and final guidance on 
topics related to the process for 
the review of in vitro clinical 
tests, and whether such guid-
ances were issued as required by 
statute or pursuant to the rec-
ommendations 
transmitted 
to 
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Congress by the Secretary pursu-
ant to subsection (b)(1)(E). 
(bb) The number and titles 
of public meetings held on topics 
related to the process for the re-
view of in vitro clinical tests, and 
if such meetings were required by 
statute or pursuant to the rec-
ommendations 
transmitted 
to 
Congress by the Secretary pursu-
ant to subsection (b)(1)(E). 
(iv) RATIONALE FOR IVCT USER FEE 
PROGRAM CHANGES.—Beginning with fis-
cal year 2022, the Secretary shall include 
in the annual performance report under 
paragraph (1)— 
(I) data, analysis, and discussion 
of the changes in the number of full- 
time equivalents hired as agreed upon 
in the recommendations transmitted 
to Congress by the Secretary pursuant 
to subsection (b)(1)(E) and the num-
ber of full-time equivalents funded by 
budget authority at the Food and 
Drug Administration by each division 
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within the Center for Devices and Ra-
diological Health, the Center for Bio-
logics Evaluation and Research, the 
Office of Regulatory Affairs, and the 
Office of the Commissioner; 
(II) data, analysis, and discus-
sion of the changes in the fee revenue 
amounts and costs for the process for 
the review of in vitro clinical tests, in-
cluding identifying drivers of such 
changes; and 
(III) for each of the Center for 
Devices and Radiological Health, the 
Center for Biologics Evaluation and 
Research, the Office of Regulatory Af-
fairs, and the Office of the Commis-
sioner, the number of employees for 
whom time reporting is required and 
the number of employees for whom 
time reporting is not required. 
(v) ANALYSIS.—For each fiscal year, 
the Secretary shall include in the report 
under clause (i) an analysis of the fol-
lowing: 
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(I) The difference between the 
aggregate number of premarket appli-
cations filed under section 587B or 
section 587D of the Federal Food, 
Drug, and Cosmetic Act and the ag-
gregate number of major deficiency 
letters, not approvable letters, and de-
nials for such applications issued by 
the agency, accounting for— 
(aa) the number of applica-
tions filed under each of sections 
587B and 587D of the Federal 
Food, Drug, and Cosmetic Act 
during one fiscal year for which a 
decision is not scheduled to be 
made until the following fiscal 
year; and 
(bb) the aggregate number 
of applications under each of sec-
tions 587B and 587D of the 
Federal Food, Drug, and Cos-
metic Act for each fiscal year 
that did not meet the goals as 
identified by the recommenda-
tions transmitted to Congress by 
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the Secretary pursuant to sub-
section (b)(1)(E). 
(II) Relevant data to determine 
whether the Center for Devices and 
Radiological Health has met perform-
ance enhancement goals identified by 
the recommendations transmitted to 
Congress by the Secretary pursuant to 
subsection (b)(1)(E). 
(III) The most common causes 
and trends for external or other cir-
cumstances affecting the ability of the 
Food and Drug Administration to 
meet review time and performance en-
hancement goals identified by the rec-
ommendations transmitted to Con-
gress by the Secretary pursuant to 
subsection (b)(1)(E). 
(B) PUBLICATION.—With regard to infor-
mation to be reported by the Food and Drug 
Administration to industry on a quarterly and 
annual basis pursuant to recommendations 
transmitted to Congress by the Secretary pur-
suant to subsection (b)(1)(E), the Secretary 
shall make such information publicly available 
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on the internet website of the Food and Drug 
Administration not later than 60 days after the 
end of each quarter or 120 days after the end 
of each fiscal year, respectively, to which such 
information applies. 
(C) UPDATES.—The Secretary shall in-
clude in each report under subparagraph (A) 
information on all previous cohorts for which 
the Secretary has not given a complete response 
on all in vitro clinical test premarket applica-
tions and technology certification orders and 
supplements, premarket, and technology certifi-
cation notifications in the cohort. 
(2) CORRECTIVE ACTION REPORT.—Beginning 
with fiscal year 2022, for each fiscal year for which 
fees are collected under this section, the Secretary 
shall prepare and submit a corrective action report 
to the Committee on Health, Education, Labor, and 
Pensions and the Committee on Appropriations of 
the Senate and the Committee on Energy and Com-
merce and the Committee on Appropriations of the 
House of Representatives. The report shall include 
the following information, as applicable: 
(A) GOALS MET.—For each fiscal year, if 
the Secretary determines, based on the analysis 
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242 
under paragraph (1)(A)(v), that each of the 
goals identified by the recommendations trans-
mitted to Congress by the Secretary pursuant 
to subsection (b)(1)(E) for the applicable fiscal 
year have been met, the corrective action report 
shall include recommendations on ways in which 
the Secretary can improve and streamline the in 
vitro clinical test premarket application and 
technology certification review process. 
(B) GOALS MISSED.—For each of the goals 
identified by the letters described in rec-
ommendations transmitted to Congress by the 
Secretary pursuant to subsection (b)(1)(E) for 
the applicable fiscal year that the Secretary de-
termines to not have been met, the corrective 
action report shall include— 
(i) a justification for such determina-
tion; 
(ii) a description of the types of cir-
cumstances, in the aggregate, under which 
applications or reports submitted under 
sections 587B and 587D of the Federal 
Food, Drug, and Cosmetic Act missed the 
review goal times but were approved dur-
ing the first cycle review, as applicable; 
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(iii) a summary and any trends with 
regard to the circumstances for which a re-
view goal was missed; and 
(iv) the performance enhancement 
goals that were not achieved during the 
previous fiscal year and a description of ef-
forts the Food and Drug Administration 
has put in place for the fiscal year in 
which the report is submitted to improve 
the ability of such agency to meet each 
such goal for the such fiscal year. 
(3) FISCAL
REPORT.—For fiscal years 2021 
and annually thereafter, not later than 120 days 
after the end of each fiscal year during which fees 
are collected under this subpart, the Secretary shall 
prepare and submit to the Committee on Health, 
Education, Labor, and Pensions of the Senate and 
the Committee on Energy and Commerce of the 
House of Representatives, a report on the implemen-
tation of the authority for such fees during such fis-
cal year and the use, by the Food and Drug Admin-
istration, of the fees collected during such fiscal year 
for which the report is made. 
(A) CONTENTS.—Such report shall include 
expenditures delineated by budget authority and 
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user fee dollars related to administrative ex-
penses and information technology infrastruc-
ture contracts and expenditures. 
(B) OPERATING
RESERVE.—Such report 
shall provide the amount of operating reserve 
balance available each year, and any planned al-
locations or obligations of such balance that is 
above 10 weeks of operating reserve for the pro-
gram. 
(4) 
PUBLIC
AVAILABILITY.—The 
Secretary 
shall make the reports required under paragraphs 
(1) through (3) available to the public on the inter-
net website of the Food and Drug Administration. 
(5) ENHANCED COMMUNICATION.— 
(A) COMMUNICATIONS WITH CONGRESS.— 
Each fiscal year, as applicable and requested, 
representatives from the Centers with expertise 
in the review of in vitro clinical tests shall meet 
with representatives from the Committee on 
Health, Education, Labor, and Pensions of the 
Senate and the Committee on Energy and Com-
merce of the House of Representatives to report 
on the contents described in the reports under 
this section. 
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(B) PARTICIPATION
IN
CONGRESSIONAL 
HEARING.—Each fiscal year, as applicable and 
requested, representatives from the Food and 
Drug Administration shall participate in a pub-
lic hearing before the Committee on Health, 
Education, Labor, and Pensions of the Senate 
and the Committee on Energy and Commerce 
of the House of Representatives, to report on 
the contents described in the reports under this 
section. Such hearing shall occur not later than 
120 days after the end of each fiscal year for 
which fees are collected under this section. 
Æ 
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