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and Human Services (referred to in this section as the 
‘‘Secretary’’) shall publish a report on the public website 
of the Food and Drug Administration on the utilization 
of agreements entered into pursuant to section 809 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 384e) 
or otherwise entered into by the Secretary in the previous 
fiscal year to recognize inspections between drug regu-
latory authorities across countries and international re-
gions with analogous review criteria to the Food and Drug 
Administration, such as the Pharmaceutical Inspection 
Co-Operation Scheme, the Mutual Recognition Agreement 
with the European Union, and the Australia-Canada- 
Singapore-Switzerland-United Kingdom Consortium. 
(b) CONTENT.—The report under subsection (a) shall 
include each of the following: 
(1) The total number of establishments that are 
registered under section 510(i) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 360(i)), and the 
number of such establishments in each region of in-
terest. 
(2) The total number of inspections conducted 
at establishments described in paragraph (1), 
disaggregated by inspections conducted— 
(A) pursuant to an agreement or other rec-
ognition described in subsection (a); and 
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(B) by employees or contractors of the 
Food and Drug Administration. 
(3) Of the inspections described in paragraph 
(2), the total number of inspections in each region 
of interest. 
(4) Of the inspections in each region of interest 
reported pursuant to paragraph (3), the number of 
inspections in each FDA inspection category. 
(5) Of the number of inspections reported 
under each of paragraphs (3) and (4)— 
(A) the number of inspections which have 
been conducted pursuant to an agreement or 
other recognition described in subsection (a); 
and 
(B) the number of inspections which have 
been conducted by employees or contractors of 
the Food and Drug Administration. 
(c) DEFINITIONS.—In this section: 
(1) FDA INSPECTION
CATEGORY.—The term 
‘‘FDA inspection category’’ means the following in-
spection categories: 
(A) Inspections to support approvals of 
changes to the manufacturing process of drugs 
approved under section 505 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 355) 
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or section 351 of the Public Health Service Act 
(42 U.S.C. 262). 
(B) Surveillance inspections. 
(C) For-cause inspections. 
(2) REGION OF INTEREST.—The term ‘‘region 
of interest’’ means China, India, the European 
Union, and any other geographic region as the Sec-
retary determines appropriate. 
SEC. 729. ENHANCING TRANSPARENCY OF DRUG FACILITY 
INSPECTION TIMELINES. 
Section 902 of the FDA Reauthorization Act of 2017 
(21 U.S.C. 355 note) is amended to read as follows: 
‘‘SEC. 902. ANNUAL REPORT ON INSPECTIONS. 
‘‘Not later than 120 days after the end of each fiscal 
year, the Secretary of Health and Human Services shall 
post on the public website of the Food and Drug Adminis-
tration information related to inspections of facilities nec-
essary for approval of a drug under subsection (c) or (j) 
of section 505 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 355), approval of a device under section 
515 of such Act (21 U.S.C. 360e), or clearance of a device 
under section 510(k) of such Act (21 U.S.C. 360(k)) that 
were conducted during the previous fiscal year. Such infor-
mation shall include the following: 
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‘‘(1) The median time following a request from 
staff of the Food and Drug Administration review-
ing an application or report to the beginning of the 
inspection, including— 
‘‘(A) the median time for drugs described 
in section 505(j)(11)(A)(i) of the Federal Food, 
Drug, 
and 
Cosmetic 
Act 
(21 
U.S.C. 
355(j)(11)(A)(i)); 
‘‘(B) the median time for drugs described 
in section 506C(a) of such Act (21 U.S.C. 
356c(a)) only; and 
‘‘(C) the median time for drugs on the 
drug shortage list in effect under section 506E 
of such Act (21 U.S.C. 356e). 
‘‘(2) The median time from the issuance of a 
report pursuant to section 704(b) of such Act (21 
U.S.C. 374(b)) to the sending of a warning letter, 
issuance of an import alert, or holding of a regu-
latory meeting for inspections for which the Sec-
retary concluded that regulatory or enforcement ac-
tion was indicated, including the median time for 
each category of drugs listed in subparagraphs (A) 
through (C) of paragraph (1). 
‘‘(3) The median time from the sending of a 
warning letter, issuance of an import alert, or hold-
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ing of a regulatory meeting to resolution of the ac-
tions indicated to address the conditions or practices 
observed during an inspection. 
‘‘(4) The number of facilities that failed to im-
plement adequate corrective or preventive actions 
following a report pursuant to such section 704(b), 
resulting in a withhold recommendation, including 
the number of such times for each category of drugs 
listed in subparagraphs (A) through (C) of para-
graph (1).’’. 
TITLE 
VIII—TRANSPARENCY, 
PROGRAM 
INTEGRITY, 
AND 
REGULATORY 
IMPROVE-
MENTS 
SEC. 801. PROMPT REPORTS OF MARKETING STATUS BY 
HOLDERS OF APPROVED APPLICATIONS FOR 
BIOLOGICAL PRODUCTS. 
(a) IN GENERAL.—Section 506I of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 356i) is amended— 
(1) in subsection (a)— 
(A) in the matter preceding paragraph (1), 
by striking ‘‘The holder of an application ap-
proved under subsection (c) or (j) of section 
505’’ and inserting ‘‘The holder of an applica-
tion approved under subsection (c) or (j) of sec-
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tion 505 of this Act or subsection (a) or (k) of 
section 351 of the Public Health Service Act’’; 
(B) in paragraph (2), by striking ‘‘estab-
lished name’’ and inserting ‘‘established name 
(for biological products, by proper name)’’; and 
(C) in paragraph (3), by striking ‘‘or ab-
breviated application number’’ and inserting ‘‘, 
abbreviated application number, or biologics li-
cense application number’’; and 
(2) in subsection (b)— 
(A) in the matter preceding paragraph (1), 
by striking ‘‘The holder of an application ap-
proved under subsection (c) or (j)’’ and insert-
ing ‘‘The holder of an application approved 
under subsection (c) or (j) of section 505 of 
this Act or subsection (a) or (k) of section 351 
of the Public Health Service Act’’; 
(B) in paragraph (1), by striking ‘‘estab-
lished name’’ and inserting ‘‘established name 
(for biological products, by proper name)’’; and 
(C) in paragraph (2), by striking ‘‘or ab-
breviated application number’’ and inserting ‘‘, 
abbreviated application number, or biologics li-
cense application number’’. 
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(b) ADDITIONAL ONE-TIME REPORT.—Subsection 
(c) of section 506I of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 356i) is amended to read as follows: 
‘‘(c) ADDITIONAL ONE-TIME REPORT.—Within 180 
days of the date of enactment of the Food and Drug 
Amendments of 2022, all holders of applications approved 
under subsection (a) or (k) of section 351 of the Public 
Health Service Act shall review the information in the list 
published under section 351(k)(9)(A) and shall submit a 
written notice to the Secretary— 
‘‘(1) stating that all of the application holder’s 
biological products in the list published under sec-
tion 351(k)(9)(A) that are not listed as discontinued 
are available for sale; or 
‘‘(2) including the information required pursu-
ant to subsection (a) or (b), as applicable, for each 
of the application holder’s biological products that 
are in the list published under section 351(k)(9)(A) 
and not listed as discontinued, but have been discon-
tinued from sale or never have been available for 
sale.’’. 
(c) PURPLE BOOK.—Section 506I of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 356i) is amend-
ed— 
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(1) by striking subsection (d) and inserting the 
following: 
‘‘(d) FAILURE TO MEET REQUIREMENTS.—If a hold-
er of an approved application fails to submit the informa-
tion required under subsection (a), (b), or (c), the Sec-
retary may— 
‘‘(1) move the application holder’s drugs from 
the active section of the list published under section 
505(j)(7)(A) to the discontinued section of the list, 
except that the Secretary shall remove from the list 
in accordance with section 505(j)(7)(C) drugs the 
Secretary determines have been withdrawn from sale 
for reasons of safety or effectiveness; and 
‘‘(2) identify the application holder’s biological 
products as discontinued in the list published under 
section 351(k)(9)(A) of the Public Health Service 
Act, except that the Secretary shall remove from the 
list in accordance with section 351(k)(9)(B) of such 
Act biological products for which the license has 
been revoked or suspended for reasons of safety, pu-
rity, or potency.’’; and 
(2) in subsection (e)— 
(A) by inserting after the first sentence the 
following: ‘‘The Secretary shall update the list 
published under section 351(k)(9)(A) of the 
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Public Health Service Act based on information 
provided under subsections (a), (b), and (c) by 
identifying as discontinued biological products 
that are not available for sale, except that bio-
logical products for which the license has been 
revoked or suspended for safety, purity, or po-
tency reasons shall be removed from the list in 
accordance with section 351(k)(9)(B) of the 
Public Health Service Act.’’; 
(B) by striking ‘‘monthly updates to the 
list’’ and inserting ‘‘monthly updates to the lists 
referred to in the preceding sentences’’; and 
(C) by striking ‘‘and shall update the list 
based on’’ and inserting ‘‘and shall update such 
lists based on’’. 
(d) TECHNICAL CORRECTIONS.—Section 506I(e) of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
356i(e)) is amended— 
(1) by striking ‘‘subsection 505(j)(7)(A)’’ and 
inserting ‘‘section 505(j)(7)(A)’’; and 
(2) by striking ‘‘subsection 505(j)(7)(C)’’ and 
inserting ‘‘section 505(j)(7)(C)’’. 
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SEC. 802. ENCOURAGING BLOOD DONATION. 
(a) STREAMLINING PATIENT
AND BLOOD DONOR 
INPUT.—Section 3003 of the 21st Century Cures Act (21 
U.S.C. 360bbb–8c note) is amended to read as follows: 
‘‘SEC. 3003. STREAMLINING PATIENT AND BLOOD DONOR 
INPUT. 
‘‘Chapter 35 of title 44, United States Code, shall 
not apply to the collection of information to which a re-
sponse is voluntary, to solicit— 
‘‘(1) the views and perspectives of patients 
under section 569C of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360bbb–8c) (as amended 
by section 3001) or section 3002; or 
‘‘(2) information from blood donors or potential 
blood donors to support the development of rec-
ommendations by the Secretary of Health and 
Human Services acting through the Commissioner of 
Food and Drugs concerning blood donation.’’. 
(b) CLERICAL AMENDMENT.—The table of contents 
in section 1(b) of the 21st Century Cures Act is amended 
by striking the item relating to section 3003 and inserting 
the following: 
‘‘Sec. 3003. Streamlining patient and blood donor input.’’. 
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SEC. 803. REGULATION OF CERTAIN PRODUCTS AS DRUGS. 
Section 503 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 353) is amended by adding at the end the 
following: 
‘‘(h)(1) Any contrast agent, radioactive drug, or OTC 
monograph drug shall be deemed to be a drug under sec-
tion 201(g) and not a device under section 201(h). 
‘‘(2) For purposes of this subsection: 
‘‘(A) The term ‘contrast agent’ means an arti-
cle that is intended for use in conjunction with a 
medical imaging device, and— 
‘‘(i) is a diagnostic radiopharmaceutical, as 
defined in sections 315.2 and 601.31 of title 
21, Code of Federal Regulations (or any suc-
cessor regulations); or 
‘‘(ii) is a diagnostic agent that improves 
the visualization of structure or function within 
the body by increasing the relative difference in 
signal intensity within the target tissue, struc-
ture, or fluid. 
‘‘(B) The term ‘radioactive drug’ has the mean-
ing given such term in section 310.3(n) of title 21, 
Code of Federal Regulations (or any successor regu-
lations), except that such term does not include— 
‘‘(i) an implant or article similar to an im-
plant; 
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‘‘(ii) an article that applies radiation from 
outside of the body; or 
‘‘(iii) the radiation source of an article de-
scribed in clause (i) or (ii). 
‘‘(C) The term ‘OTC monograph drug’ has the 
meaning given such term in section 744L. 
‘‘(3) Nothing in this subsection shall be construed as 
allowing for the classification of a product as a drug (as 
defined in section 201(g)) if such product— 
‘‘(A) is not described in paragraph (1); and 
‘‘(B) meets the definition of a device under sec-
tion 201(h), 
unless another provision of this Act otherwise indicates a 
different classification.’’. 
SEC. 804. POSTAPPROVAL STUDIES AND PROGRAM INTEG-
RITY FOR ACCELERATED APPROVAL DRUGS. 
(a) IN GENERAL.—Section 506(c) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 356(c)) is 
amended— 
(1) by striking paragraph (2) and inserting the 
following: 
‘‘(2) LIMITATION.— 
‘‘(A) IN GENERAL.—Approval of a product 
under this subsection may be subject to 1 or 
both of the following requirements: 
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‘‘(i) That the sponsor conduct an ap-
propriate postapproval study or studies 
(which may be augmented or supported by 
real world evidence) to verify and describe 
the predicted effect on irreversible mor-
bidity or mortality or other clinical benefit. 
‘‘(ii) That the sponsor submit copies 
of all promotional materials related to the 
product during the preapproval review pe-
riod and, following approval and for such 
period thereafter as the Secretary deter-
mines to be appropriate, at least 30 days 
prior to dissemination of the materials. 
‘‘(B) STUDIES
NOT
REQUIRED.—If the 
Secretary does not require that the sponsor of 
a product approved under accelerated approval 
conduct a postapproval study under this para-
graph, the Secretary shall publish on the 
website of the Food and Drug Administration 
the rationale for why such study is not appro-
priate or necessary. 
‘‘(C) 
POSTAPPROVAL
STUDY
CONDI-
TIONS.—Not later than the time of approval of 
a product under accelerated approval, the Sec-
retary shall specify the conditions for a post-
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approval study or studies required to be con-
ducted under this paragraph with respect to 
such product, which may include enrollment 
targets, the study protocol, and milestones, in-
cluding the target date of study completion. 
‘‘(D) 
STUDIES
BEGUN
BEFORE
AP-
PROVAL.—The Secretary may require such 
study or studies to be underway prior to ap-
proval.’’; and 
(2) by striking paragraph (3) and inserting the 
following: 
‘‘(3) 
EXPEDITED
WITHDRAWAL
OF
AP-
PROVAL.— 
‘‘(A) IN
GENERAL.—The Secretary may 
withdraw approval of a product approved under 
accelerated approval using expedited procedures 
described in subparagraph (B), if— 
‘‘(i) the sponsor fails to conduct any 
required postapproval study of the product 
with due diligence, including with respect 
to conditions specified by the Secretary 
under paragraph (2)(C); 
‘‘(ii) a study required to verify and 
describe the predicted effect on irreversible 
morbidity or mortality or other clinical 
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benefit of the product fails to verify and 
describe such effect or benefit; 
‘‘(iii) other evidence demonstrates 
that the product is not shown to be safe or 
effective under the conditions of use; or 
‘‘(iv) the sponsor disseminates false or 
misleading promotional materials with re-
spect to the product. 
‘‘(B) 
EXPEDITED
PROCEDURES
DE-
SCRIBED.—Expedited procedures described in 
this subparagraph shall consist of, prior to the 
withdrawal of accelerated approval— 
‘‘(i) providing the sponsor with— 
‘‘(I) due notice; 
‘‘(II) an explanation for the pro-
posed withdrawal; 
‘‘(III) an opportunity for a meet-
ing with the Commissioner of Food 
and Drugs or the Commissioner’s des-
ignee; and 
‘‘(IV) an opportunity for written 
appeal to— 
‘‘(aa) the Commissioner of 
Food and Drugs; or 
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‘‘(bb) a designee of the 
Commissioner who has not par-
ticipated in the proposed with-
drawal of approval (other than a 
meeting pursuant to subclause 
(III)) and is not a subordinate of 
an individual (other than the 
Commissioner) who participated 
in such proposed withdrawal; 
‘‘(ii) providing an opportunity for 
public comment on the notice proposing to 
withdraw approval; 
‘‘(iii) the publication of a summary of 
the public comments received, and the Sec-
retary’s response to such comments, on the 
website of the Food and Drug Administra-
tion; and 
‘‘(iv) convening and consulting an ad-
visory committee on issues related to the 
proposed withdrawal, if requested by the 
sponsor and if no such advisory committee 
has previously advised the Secretary on 
such issues with respect to the withdrawal 
of the product prior to the sponsor’s re-
quest. 
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‘‘(4) LABELING.— 
‘‘(A) IN
GENERAL.—Subject to subpara-
graph (B), the labeling for a product approved 
under accelerated approval shall include— 
‘‘(i) a statement indicating that the 
product was approved under accelerated 
approval; 
‘‘(ii) a statement indicating that con-
tinued approval of the product is subject to 
postmarketing studies to verify clinical 
benefit; 
‘‘(iii) identification of the surrogate or 
intermediate endpoint or endpoints that 
supported approval and any known limita-
tions of such surrogate or intermediate 
endpoint or endpoints in determining clin-
ical benefit; and 
‘‘(iv) a succinct description of the 
product and any uncertainty about antici-
pated clinical benefit and a discussion of 
available evidence with respect to such clin-
ical benefit. 
‘‘(B) APPLICABILITY.—The labeling re-
quirements of subparagraph (A) shall apply 
only to products approved under accelerated ap-
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proval for which the predicted effect on irre-
versible morbidity or mortality or other clinical 
benefit has not been verified. 
‘‘(C) RULE OF CONSTRUCTION.—With re-
spect to any application pending before the Sec-
retary on the date of enactment of the Food 
and Drug Amendments of 2022, the Secretary 
shall allow any applicable changes to the prod-
uct labeling required to comply with subpara-
graph (A) to be made by supplement after the 
approval of such application. 
‘‘(5) REPORTING.—Not later than September 
30, 2025, the Secretary shall submit to the Com-
mittee on Energy and Commerce of the House of 
Representatives and the Committee on Health, Edu-
cation, Labor, and Pensions of the Senate a report 
describing circumstances in which the Secretary con-
sidered real world evidence submitted to support 
postapproval studies required under this subsection 
that were completed after the date of enactment of 
the Food and Drug Amendments of 2022.’’. 
(b) REPORTS OF POSTMARKETING STUDIES.—Sec-
tion 506B(a) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 356b(a)) is amended— 
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(1) by redesignating paragraph (2) as para-
graph (3); and 
(2) by inserting after paragraph (1) the fol-
lowing: 
‘‘(2) 
ACCELERATED
APPROVAL.—Notwith-
standing paragraph (1), a sponsor of a drug ap-
proved under accelerated approval shall submit to 
the Secretary a report of the progress of any study 
required under section 506(c), including progress to-
ward enrollment targets, milestones, and other infor-
mation as required by the Secretary, not later than 
180 days after the approval of such drug and not 
less frequently than every 180 days thereafter, until 
the study is completed or terminated.’’. 
(c) GUIDANCE.— 
(1) IN GENERAL.—The Secretary of Health and 
Human Services shall issue guidance describing— 
(A) how sponsor questions related to the 
identification of novel surrogate or intermediate 
clinical endpoints may be addressed in early- 
stage development meetings with the Food and 
Drug Administration; 
(B) the use of novel clinical trial designs 
that may be used to conduct appropriate post-
approval studies as may be required under sec-
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tion 506(c)(2)(A) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 356(c)(2)(A)), as 
amended by subsection (a); and 
(C) the expedited procedures described in 
section 506(c)(3)(B) of the Federal Food, 
Drug, 
and 
Cosmetic 
Act 
(21 
U.S.C. 
356(c)(3)(B)). 
(2) FINAL
GUIDANCE.—The Secretary shall 
issue— 
(A) draft guidance under paragraph (1) 
not later than 18 months after the date of en-
actment of this Act; and 
(B) final guidance not later than 1 year 
after the close of the public comment period on 
such draft guidance. 
(d) RARE
DISEASE
ENDPOINT
ADVANCEMENT 
PILOT.— 
(1) IN GENERAL.—The Secretary of Health and 
Human Services shall establish a pilot program 
under which the Secretary will establish procedures 
to provide increased interaction with sponsors of 
rare disease drug development programs for pur-
poses of advancing the development of efficacy 
endpoints, including surrogate and intermediate 
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endpoints, for drugs intended to treat rare diseases, 
including through— 
(A) determining eligibility of participants 
for such a program; and 
(B) developing and implementing a process 
for applying to, and participating in, such a 
program. 
(2) PUBLIC WORKSHOPS.—The Secretary shall 
conduct up to 3 public workshops, which shall be 
completed not later than September 30, 2026, to 
discuss topics relevant to the development of 
endpoints for rare diseases, which may include dis-
cussions about— 
(A) novel endpoints developed through the 
pilot program established under this subsection; 
and 
(B) as appropriate, the use of real world 
evidence and real world data to support the val-
idation of efficacy endpoints, including surro-
gate and intermediate endpoints, for rare dis-
eases. 
(3) REPORT.—Not later than September 30, 
2027, the Secretary shall submit to the Committee 
on Energy and Commerce of the House of Rep-
resentatives and the Committee on Health, Edu-
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cation, Labor, and Pensions of the Senate a report 
describing the outcomes of the pilot program estab-
lished under this subsection. 
(4) GUIDANCE.—Not later than September 30, 
2027, the Secretary shall issue guidance describing 
best practices and strategies for development of effi-
cacy endpoints, including surrogate and intermediate 
endpoints, for rare diseases. 
(5) SUNSET.—The Secretary may not accept 
any new application or request to participate in the 
program established by this subsection on or after 
October 1, 2027. 
SEC. 805. FACILITATING THE USE OF REAL WORLD EVI-
DENCE. 
(a) GUIDANCE.—Not later than 1 year after the date 
of the enactment of this Act, the Secretary of Health and 
Human Services shall issue, or revise existing, guidance 
on considerations for the use of real world data and real 
world evidence to support regulatory decisionmaking, as 
follows: 
(1) With respect to drugs, such guidance shall 
address— 
(A) the use of such data and evidence to 
support the approval of a drug application 
under section 505 of the Federal Food, Drug, 
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and Cosmetic Act (21 U.S.C. 355) or a biologi-
cal product application under section 351 of the 
Public Health Service Act (42 U.S.C. 262), or 
to support an investigational use exemption 
under section 505(i) of the Federal Food, Drug, 
and Cosmetic Act or section 351(a)(3) of the 
Public Health Service Act; and 
(B) the use of such data and evidence ob-
tained as a result of the use of drugs author-
ized for emergency use under section 564 of the 
Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 360bbb–3) in such applications, submis-
sions, or requests; and 
(C) standards and methodologies which 
may be used for collection and analysis of real 
world evidence included in such applications, 
submissions, or requests, as appropriate. 
(2) With respect to devices, such guidance shall 
address— 
(A) the use of such data and evidence to 
support the approval, clearance, or classification 
of a device pursuant to an application or sub-
mission 
submitted 
under 
section 
510(k), 
513(f)(2), or 515 of the Federal Food, Drug, 
and 
Cosmetic 
Act 
(21 
U.S.C. 
360(k), 
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360c(f)(2), 360e), or to support an investiga-
tional use exemption under section 520(g) of 
such Act (21 U.S.C. 360j(g)); 
(B) the use of such data and evidence ob-
tained as a result of the use of devices author-
ized for emergency use under section 564 of the 
Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 360bbb–3), in such applications, submis-
sions, or requests; and 
(C) standards and methodologies which 
may be used for collection and analysis of real 
world evidence included in such applications, 
submissions, or requests, as appropriate. 
(b) REPORT TO CONGRESS.—Not later than 2 years 
after the termination of the public health emergency deter-
mination by the Secretary of Health and Human Services 
under section 564 of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 360bbb–3) on February 4, 2020, 
with respect to the Coronavirus Disease 2019 (COVID– 
19), the Secretary shall submit a report to the Committee 
on Energy and Commerce of the House of Representatives 
and the Committee on Health, Education, Labor, and 
Pensions of the Senate on— 
(1) the number of applications, submissions, or 
requests submitted for clearance or approval under 
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section 505, 510(k), 513(f)(2), or 515 of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 355, 
360(k), 360c(f)(2), 360e) or section 351 of the Pub-
lic Health Service Act, for which an authorization 
under section 564 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360bbb–3) was previously 
granted; 
(2) of the number of applications so submitted, 
the number of such applications— 
(A) for which real world evidence was sub-
mitted and used to support a regulatory deci-
sion; and 
(B) for which real world evidence was sub-
mitted and determined to be insufficient to sup-
port a regulatory decision; and 
(3) a summary explanation of why, in the case 
of applications described in paragraph (2)(B), real 
world evidence could not be used to support regu-
latory decisions. 
(c) INFORMATION DISCLOSURE.—Nothing in this 
section shall be construed to authorize the disclosure of 
information that is prohibited from disclosure under sec-
tion 1905 of title 18, United States Code, or subject to 
withholding under subsection (b)(4) of section 552 of title 
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5, United States Code (commonly referred to as the 
‘‘Freedom of Information Act’’). 
SEC. 806. DUAL SUBMISSION FOR CERTAIN DEVICES. 
Section 513 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 360c) is amended by adding at the end 
the following: 
‘‘(k) For a device authorized for emergency use under 
section 564 for which, in accordance with section 564(m), 
the Secretary has deemed a laboratory examination or pro-
cedure associated with such device to be in the category 
of examinations and procedures described in section 
353(d)(3) of the Public Health Service Act, the sponsor 
of such device may, when submitting a request for classi-
fication under section 513(f)(2), submit a single submis-
sion containing— 
‘‘(1) the information needed for such a request; 
and 
‘‘(2) sufficient information to enable the Sec-
retary to determine whether such laboratory exam-
ination or procedure satisfies the criteria to be cat-
egorized under section 353(d)(3) of the Public 
Health Service Act.’’. 
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SEC. 807. MEDICAL DEVICES ADVISORY COMMITTEE MEET-
INGS. 
(a) IN GENERAL.—The Secretary shall convene one 
or more panels of the Medical Devices Advisory Committee 
not less than once per year for the purpose of providing 
advice to the Secretary on topics related to medical devices 
used in pandemic preparedness and response, including 
topics related to in vitro diagnostics. 
(b) REQUIRED PANEL MEMBER.—A panel convened 
under subsection (a) shall include at least 1 population 
health-specific representative. 
(c) SUNSET.—This section shall cease to be effective 
on October 1, 2027. 
SEC. 808. ENSURING CYBERSECURITY OF MEDICAL DE-
VICES. 
(a) IN GENERAL.—Subchapter A of chapter V of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351 
et seq.), as amended by section 501, is further amended 
by adding at the end the following: 
‘‘SEC. 524C. ENSURING CYBERSECURITY OF DEVICES. 
‘‘(a) IN GENERAL.—For purposes of ensuring cyber-
security throughout the lifecycle of a cyber device, any per-
son who submits a premarket submission for the cyber de-
vice shall include such information as the Secretary may 
require to ensure that the cyber device meets such cyberse-
curity requirements as the Secretary determines to be ap-
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propriate to demonstrate a reasonable assurance of safety 
and effectiveness, including at a minimum the cybersecu-
rity requirements under subsection (b). 
‘‘(b) CYBERSECURITY REQUIREMENTS.—At a min-
imum, the manufacturer of a cyber device shall meet the 
following cybersecurity requirements: 
‘‘(1) The manufacturer shall have a plan to ap-
propriately monitor, identify, and address in a rea-
sonable time postmarket cybersecurity vulnerabilities 
and exploits, including coordinated vulnerability dis-
closure and procedures. 
‘‘(2) The manufacturer shall design, develop, 
and maintain processes and procedures to ensure the 
device and related systems are cybersecure, and shall 
make available updates and patches to the cyber de-
vice and related systems throughout the lifecycle of 
the cyber device to address— 
‘‘(A) on a reasonably justified regular 
cycle, known unacceptable vulnerabilities; and 
‘‘(B) as soon as possible out of cycle, crit-
ical vulnerabilities that could cause uncontrolled 
risks. 
‘‘(3) The manufacturer shall provide in the la-
beling of the cyber device a software bill of mate-
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rials, including commercial, open-source, and off-the- 
shelf software components. 
‘‘(4) The manufacturer shall comply with such 
other requirements as the Secretary may require to 
demonstrate reasonable assurance of the safety and 
effectiveness of the device for purposes of cybersecu-
rity, which the Secretary may require by an order 
published in the Federal Register. 
‘‘(c) SUBSTANTIAL EQUIVALENCE.—In making a de-
termination of substantial equivalence under section 
513(i) for a cyber device, the Secretary may— 
‘‘(1) find that cybersecurity information for the 
cyber device described in the relevant premarket 
submission in the cyber device’s use environment is 
inadequate; and 
‘‘(2) issue a nonsubstantial equivalence deter-
mination based on this finding. 
‘‘(d) DEFINITION.—In this section: 
‘‘(1) CYBER DEVICE.—The term ‘cyber device’ 
means a device that— 
‘‘(A) includes software, including software 
as or in a device; 
‘‘(B) has the ability to connect to the 
internet; or 
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