203 
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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204 
(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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205 
(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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206 
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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207 
(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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208 
(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) EFFECTIVE DATE.— 
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209 
(A) IN
GENERAL.—Except as otherwise 
provided in this section, the amendments made 
by this Act apply 4 years after the date of en-
actment of this Act (in this section and in sub-
chapter J of chapter V of the Federal Food, 
Drug, and Cosmetic Act, as added by this Act, 
referred to in this section as the ‘‘effective date 
of this Act’’). 
(B) EXCEPTION.—The Secretary of Health 
and Human Services (in this section referred to 
as the ‘‘Secretary’’) may take the actions de-
scribed in paragraph (2), and may expend such 
funds as the Secretary determines necessary to 
ensure an orderly transition. 
(2) ACTIONS.—The Secretary shall, prior to the 
date on which the amendments made by this Act 
generally apply pursuant to paragraph (1)— 
(A) within 1 year of the date of enactment 
of this Act hold the public meetings described 
in subchapter J of chapter V of the Federal 
Food, Drug, and Cosmetic Act, as added by 
section 3; 
(B) within 2 years of the date of enact-
ment of this Act promulgate final regulations 
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required under sections 587B, 587D, 587L, 
587M, 587V, and 587W; and 
(C) within 2 years of the date of enact-
ment of this Act issue final guidance on appli-
cability requirements under section 587A. 
(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 
under this section. 
(b) APPLICATION
OF AUTHORITIES
TO IN VITRO 
CLINICAL TESTS UNTIL AND AFTER EFFECTIVE DATE 
OF THIS ACT.—Except as provided in subsections (c) and 
(d), for any in vitro clinical test as defined in section 
201(ss) of the Federal Food, Drug, and Cosmetic Act, as 
added by this Act, the following authorities shall apply: 
(1) TESTS OFFERED PRIOR TO ENACTMENT.— 
An in vitro clinical test that meets the criteria for 
a grandfathered test as set forth in section 
587A(c)(2) of the Federal Food, Drug, and Cos-
metic Act, as added by section 3, may continue to 
be offered for clinical use and shall be subject only 
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211 
to applicable provisions of section 353 of the Public 
Health Service Act and section 587A(a)(4) of the 
Federal Food, Drug, and Cosmetic Act, as added by 
section 3. 
(2) TESTS
APPROVED
OR
CLEARED
ON
OR 
AFTER THE DATE OF ENACTMENT BUT PRIOR TO 
THE EFFECTIVE DATE.—Before any in vitro clinical 
test as defined in section 201(ss) of the Federal 
Food, Drug, and Cosmetic Act, as added by this 
Act, is first offered, sold, or distributed after the 
date of enactment of this Act, but prior to the effec-
tive date of this Act, such product or test shall be 
considered a transitional test as described under 
subsection (c) and comply with the applicable device 
provisions of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 301 et seq.) and the Public Health 
Service Act (42 U.S.C. 201 et seq.). 
(3) TESTS UNDER FDA REVIEW BEGINNING ON 
OR AFTER THE DATE OF ENACTMENT OF THIS ACT 
BUT PRIOR TO IMPLEMENTATION.—For any in vitro 
clinical test as defined in section 201(ss) of the Fed-
eral Food, Drug, and Cosmetic Act, as added by this 
Act, for which a submission for marketing authoriza-
tion under section 515, clearance under section 
510(k), authorization under section 513(f)(2), ap-
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proval under section 520(m), or emergency use au-
thorization 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 sub-
mission after the effective date of this Act according 
to the statutory provision under which such submis-
sion was submitted. 
(c) APPLICATION
OF
AUTHORITIES
TO
TRANSI-
TIONAL
AND
GRANDFATHERED
IN
VITRO
CLINICAL 
TESTS.— 
(1) DEFINITION.—For purposes of this section, 
the term ‘‘transitional in vitro clinical test’’ means 
an in vitro clinical test, as defined in section 201(ss) 
of the Federal Food, Drug, and Cosmetic Act, as 
added by this Act, that— 
(A) is offered for clinical use during the 
period beginning on the date of enactment of 
this Act and ending on the date that is 90 days 
after the effective date of this Act; 
(B) is developed by a clinical laboratory 
certified by the Secretary under section 353 of 
the Public Health Service Act (42 U.S.C. 263a) 
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213 
that meets the requirements for performing 
high-complexity testing for use only within that 
certified laboratory or another laboratory within 
the organization under common ownership; and 
(C) is not approved under section 515, 
cleared under section 510(k), authorized under 
section 513(f)(2), subject to an exemption 
under section 520(m), or authorized under sec-
tion 564 of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 360e, 360(k), 360c(f)(2), 
360j(m), 360bbb–3) or approval under the Pub-
lic Health Service Act (42 U.S.C. 201 et seq.). 
(2) 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 prior to the ef-
fective date of this Act may continue to be offered, 
sold, or distributed until completion of the Sec-
retary’s review of the premarket application or tech-
nology certification application. 
(d) CONVERSION.— 
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214 
(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— 
(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. 
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215 
(e) INSTRUMENTS.—An instrument (as defined in 
section 587 of the Federal Food, Drug, and Cosmetic Act, 
as added by this Act) that was purchased prior to the date 
of enactment of this Act and was not cleared, authorized, 
or approved by the Food and Drug Administration or part 
of an instrument family that was cleared, authorized, or 
approved by the Food and Drug Administration at the 
time of purchase may continue to be used by the purchaser 
to develop and introduce into interstate commerce an in 
vitro clinical test during the period beginning on the date 
of enactment of this Act and ending 5 years after such 
date of enactment. Beginning at the end of such period, 
any new in vitro clinical test that is developed and 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— 
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(1) in paragraphs (1) and (4)(C) of subsection 
(a), by inserting ‘‘in vitro clinical test,’’ before ‘‘or 
biological product’’ each place such term appears; 
and 
(2) in subsection (e)(3)— 
(A) in subparagraph (B), by striking 
‘‘and’’ at the end; 
(B) in subparagraph (C), by striking the 
period and inserting ‘‘; and’’; and 
(C) by adding at the end the following: 
‘‘(D) quality system requirements (with 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’’; 
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(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-
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 
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218 
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-
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 
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219 
(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 
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)— 
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(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-
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: 
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‘‘(I) This paragraph shall not apply to a 
combination product constituted of a device and 
an in vitro clinical test.’’; and 
(7) in paragraph (9)— 
(A) in subparagraph (C)(i), by striking ‘‘or 
520(g)’’ and inserting ‘‘520(g), or 587B’’; and 
(B) in subparagraph (D), by striking ‘‘or 
520’’ and inserting ‘‘520, or 587B’’. 
(b) CLASSIFICATION OF PRODUCTS.—Section 563 of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360bbb–2) is amended by adding at the end the following: 
‘‘(d) EXEMPTION.—This section shall not apply to a 
combination product constituted of a device and an in 
vitro clinical test.’’. 
SEC. 9. RESOURCES. 
(a) FINDINGS.—Congress finds that the fees 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.— 
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(A) IN
GENERAL.—Beginning not later 
than October 1, 2021, the Secretary of Health 
and Human Services (in this section referred to 
as the ‘‘Secretary’’) shall develop 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 2022. In developing 
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 
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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); 
(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 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 
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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-
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.— 
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(i) IN
GENERAL.—Not later than 
June 1, 2021, the Secretary shall transmit 
to Congress the revised recommendations 
under subparagraph (A), a summary of the 
views and comments received under such 
subparagraph, and any changes made to 
the recommendations in response to such 
views and comments. 
(ii) 
RECOMMENDATION
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 
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the 10-week operating reserve within 
2 years of the establishment of the 
program; 
(IV) include an operating reserve 
adjustment such that, if the Secretary 
has an operating reserve balance in 
excess of 10 weeks of such operating 
reserves, the Secretary shall decrease 
such fee revenue and fees to provide 
for not more than 10 weeks of such 
operating reserves; 
(V) if an adjustment is made as 
described in subclause (IV), provide 
the rationale for the amount of the 
decrease in fee revenue and fees shall 
be contained in the Federal Register; 
and 
(VI) provide that the fees 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-
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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 
website of the Food and Drug Administration 
the revised recommendations under subpara-
graph (A), a summary of the views and com-
ments 
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 website of the Food 
and Drug Administration, minutes of all 
negotiation meetings conducted under this 
subsection between the Food and Drug Ad-
ministration and the regulated industry. 
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(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. 
(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 
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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. 
(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. 
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(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-
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 
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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, 
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 
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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 
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. 
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(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 
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 
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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 
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 
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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. 
(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 
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(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.— 
(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 website of the Food 
and Drug Administration for such 
quarter and on a cumulative basis for 
such fiscal year, and may remove du-
plicative 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 
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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 
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 
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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 
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. 
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(v) ANALYSIS.—For each fiscal year, 
the Secretary shall include in the report 
under clause (i) an analysis of the fol-
lowing: 
(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-
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metic Act for each fiscal year 
that did not meet the goals as 
identified by the recommenda-
tions transmitted to Congress by 
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 
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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 
on the website of the Food and Drug Adminis-
tration 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 informa-
tion 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 
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House of Representatives. The report shall include 
the following information, as applicable: 
(A) GOALS MET.—For each fiscal year, if 
the Secretary determines, based on the analysis 
under paragraph (1)(A)(v), that each of the 
goals identified by the recommendations 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 
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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; 
(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-
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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 
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 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-
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merce of the House of Representatives to report 
on the contents described in the reports under 
this section. 
(B) PARTICIPATION
IN
CONGRESSIONAL 
HEARING.—Each fiscal year, as applicable and 
requested, representatives from the Food and 
Drug Administration shall participate in a 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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