176 
‘‘(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.
177 
‘‘(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-
178 
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—
179 
(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-
180 
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
181 
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-
182 
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,
183 
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),
184 
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
185 
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
186 
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.’’.
187 
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-
189 
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
190 
‘‘(C) contains any such technological char-
acteristics that could be vulnerable to cyberse-
curity threats. 
‘‘(2) LIFECYCLE OF THE CYBER DEVICE.—The 
term ‘lifecycle of the cyber device’ includes the 
postmarket lifecycle of the cyber device. 
‘‘(3) PREMARKET SUBMISSION.—The term ‘pre-
market submission’ means any submission under 
section 510(k), 513, 515(c), 515(f), or 520(m). 
‘‘(e) EXEMPTION.—The Secretary may identify de-
vices or types of devices that are exempt from meeting 
the cybersecurity requirements established by this section 
and regulations promulgated pursuant to this section. The 
Secretary shall publish in the Federal Register, and up-
date, as appropriate, a list of the devices and types of de-
vices so identified by the Secretary.’’. 
(b) PROHIBITED ACT.—Section 301(q) of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 331(q)) 
is amended by adding at the end the following: 
‘‘(3) The failure to comply with any requirement 
under section 524C (relating to ensuring device cybersecu-
rity).’’. 
(c) ADULTERATION.—Section 501 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 351) is amend-
ed by inserting after paragraph (j) the following:
191 
‘‘(k) If it is a device subject to the requirements set 
forth in section 524C (relating to ensuring device cyberse-
curity) and fails to comply with any requirement under 
that section.’’. 
(d) MISBRANDING.—Section 502(t) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 352(t)) is 
amended— 
(1) by striking ‘‘or (3)’’ and inserting ‘‘(3)’’; 
and 
(2) by inserting before the period at the end the 
following: ‘‘, or (4) to furnish a software bill of ma-
terials as required under section 524C (relating to 
ensuring device cybersecurity)’’. 
SEC. 809. PUBLIC DOCKET ON PROPOSED CHANGES TO 
THIRD-PARTY VENDORS. 
(a) IN GENERAL.— 
(1) OPENING PUBLIC DOCKET.—Not later than 
90 days after the date of enactment of this Act, the 
Secretary of Health and Human Services shall open 
a single public docket to solicit comments on factors 
that generally should be considered by the Secretary 
when reviewing requests from sponsors of drugs sub-
ject to risk evaluation and mitigation strategies to 
change third-party vendors engaged by sponsors to
192 
aid in implementation and management of the strat-
egies. 
(2) FACTORS.—Such factors include the poten-
tial effects of changes in third-party vendors on— 
(A) patient access; and 
(B) prescribing and administration of the 
drugs by health care providers. 
(3) CLOSING PUBLIC DOCKET.—The Secretary 
of Health and Human Services may close such pub-
lic docket not earlier than 90 days after such docket 
is opened. 
(4) NO DELAY.—Nothing in this section shall 
delay agency action on any modification to a risk 
evaluation and mitigation strategy. 
(b) GAO REPORT.—Not later than December 31, 
2026, the Comptroller General of the United States shall 
submit to the Committee on Energy and Commerce of the 
House of Representatives and the Committee on Health, 
Education, Labor, and Pensions of the Senate a report 
on— 
(1) the number of changes in third-party ven-
dors (engaged by sponsors to aid implementation 
and management of risk evaluation and mitigation 
strategies) for an approved risk evaluation and miti-
gation strategy the Secretary of Health and Human
193 
Services has approved under section 505–1(h) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
355–1(h)); 
(2) any issues affecting patient access to the 
drug that is subject to the strategy or considerations 
with respect to the administration or prescribing of 
such drug by health care providers that arose as a 
result of such modifications; and 
(3) how such issues were resolved, as applica-
ble. 
SEC. 810. FACILITATING EXCHANGE OF PRODUCT INFOR-
MATION PRIOR TO APPROVAL. 
(a) IN GENERAL.—Section 502 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 352) is amended— 
(1) in paragraph (a)— 
(A) by striking ‘‘drugs for coverage’’ and 
inserting ‘‘drugs or devices for coverage’’; and 
(B) by striking ‘‘drug’’ each place it ap-
pears and inserting ‘‘drug or device’’, respec-
tively; 
(2) in paragraphs (a)(1) and (a)(2)(B), by 
striking ‘‘under section 505 or under section 351 of 
the Public Health Service Act’’ and inserting ‘‘under 
section 505, 510(k), 513(f)(2), or 515 of this Act or 
section 351 of the Public Health Service Act’’;
194 
(3) in paragraph (a)(1)— 
(A) by striking ‘‘under section 505 or 
under section 351(a) of the Public Health Serv-
ice Act’’ and inserting ‘‘under section 505, 
510(k), 513(f)(2), or 515 of this Act or section 
351 of the Public Health Service Act’’; and 
(B) by striking ‘‘in section 505(a) or in 
subsections (a) and (k) of section 351 of the 
Public Health Service Act’’ and inserting ‘‘in 
section 505, 510(k), 513(f)(2), or 515 of this 
Act or section 351 of the Public Health Service 
Act’’; and 
(4) by adding at the end the following: 
‘‘(gg)(1) Unless its labeling bears adequate directions 
for use in accordance with paragraph (f), except that (in 
addition to drugs or devices that conform with exemptions 
pursuant to such paragraph) no drug or device shall be 
deemed to be misbranded under such paragraph through 
the provision of product information to a payor, formulary 
committee, or other similar entity with knowledge and ex-
pertise in the area of health care economic analysis car-
rying out its responsibilities for the selection of drugs or 
devices for coverage or reimbursement if the product infor-
mation relates to an investigational drug or device or in-
vestigational use of a drug or device that is approved,