I
119THCONGRESS
1
STSESSION H. R. 2372
To amend the Federal Food, Drug, and Cosmetic Act to enhance medical
device communications and ensure device cleanliness.
IN THE HOUSE OF REPRESENTATIVES
MARCH26, 2025
Mr. L
IEU(for himself, Ms. CHU, and Ms. NORTON) introduced the following
bill; which was referred to the Committee on Energy and Commerce
A BILL
To amend the Federal Food, Drug, and Cosmetic Act to
enhance medical device communications and ensure de-
vice cleanliness.
Be it enacted by the Senate and House of Representa-1
tives of the United States of America in Congress assembled, 2
SECTION 1. SHORT TITLE. 3
This Act may be cited as the ‘‘Disclosure; and En-4
couragement of Verification, Innovation, Cleaning, and 5
Efficiency Act of 2025’’ or the ‘‘DEVICE Act of 2025’’. 6
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SEC. 2. REPORTING REQUIREMENT FOR DESIGN AND RE-1
PROCESSING INSTRUCTION CHANGES. 2
(a) A
DULTERATION.—Section 501 of the Federal 3
Food, Drug, and Cosmetic Act (21 U.S.C. 351) is amend-4
ed by inserting after paragraph (j) the following: 5
‘‘(k) If it is a device with respect to which the manu-6
facturer is in violation of the reporting requirement under 7
section 510(r) (relating to design and reprocessing 8
changes).’’. 9
(b) R
EQUIREMENT.—Section 510 of the Federal 10
Food, Drug, and Cosmetic Act (21 U.S.C. 360) is amend-11
ed by adding at the end the following: 12
‘‘(r) R
EPORTINGREQUIREMENT FOR DEVICEDE-13
SIGNCHANGES.—Before making a change to the design 14
of a device, or the reprocessing instructions of a device, 15
that is marketed in interstate commerce, the manufacturer 16
of the device shall give written notice of the change to 17
the Secretary.’’. 18
SEC. 3. REPORTING REQUIREMENT FOR CERTAIN COMMU-19
NICATIONS TO FOREIGN HEALTH CARE PRO-20
VIDERS. 21
(a) A
DULTERATION.—Section 501 of the Federal 22
Food, Drug, and Cosmetic Act (21 U.S.C. 351), as 23
amended by section 2 of this Act, is further amended by 24
inserting after paragraph (k) the following: 25
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‘‘(l) If it is a device with respect to which the manu-1
facturer is in violation of the reporting requirement under 2
section 510(s) (relating to communications to foreign 3
health care providers).’’. 4
(b) R
EQUIREMENT.—Section 510 of the Federal 5
Food, Drug, and Cosmetic Act (21 U.S.C. 360), as 6
amended by section 2 of this Act, is further amended by 7
adding at the end the following: 8
‘‘(s) R
EPORTINGREQUIREMENT FOR CERTAINCOM-9
MUNICATIONS TOFOREIGNHEALTHCAREPROVIDERS.— 10
‘‘(1) R
EQUIREMENT.—The manufacturer of a 11
device that is marketed in interstate commerce shall 12
give written notice to the Secretary of any commu-13
nication described in paragraph (2) not more than 14
5 calendar days after making such communication. 15
‘‘(2) C
OMMUNICATION DESCRIBED .—A commu-16
nication is described in this paragraph if the com-17
munication— 18
‘‘(A) is made by the manufacturer of the 19
device or an affiliate of the manufacturer; 20
‘‘(B) relates to a change to the design of 21
the device, a change to the recommended re-22
processing protocols, if any, for the device, or a 23
safety concern about the device; and 24
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‘‘(C) is widely disseminated (including on a 1
voluntary basis) to health care providers in a 2
foreign country. 3
‘‘(3) A
FFILIATE.—In this subsection, the term 4
‘affiliate’ means a business entity that has a rela-5
tionship with a second business entity if, directly or 6
indirectly— 7
‘‘(A) one business entity controls, or has 8
the power to control, the other business entity; 9
or 10
‘‘(B) a third party controls, or has the 11
power to control, both of the business entities.’’. 12
SEC. 4. RAPID ASSESSMENT TESTS INTENDED TO ENSURE 13
PROPER REPROCESSING. 14
(a) I
NCLUSION IN DEVICEDEFINITION.—Section 15
201 of the Federal Food, Drug, and Cosmetic Act (21 16
U.S.C. 321) is amended— 17
(1) in paragraph (h)(1)— 18
(A) in clause (B), by striking ‘‘or’’ at the 19
end; 20
(B) in clause (C), by striking ‘‘and’’ at the 21
end and inserting ‘‘or’’; and 22
(C) by inserting after clause (C) the fol-23
lowing: 24
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‘‘(D) a rapid assessment test intended to ensure the 1
proper reprocessing of a reusable device (as defined in 2
paragraph (tt)), and’’; and 3
(2) by adding at the end the following: 4
‘‘(tt) The term ‘reusable device’ means a device 5
that— 6
‘‘(1) is intended to be used more than one time; 7
and 8
‘‘(2) must be sanitized (whether through clean-9
ing, disinfection, or sterilization) to ensure that the 10
device is safe and effective for such intended use.’’. 11
(b) I
NSTRUCTIONS FOR USE AND VALIDATION 12
D
ATA.—Section 510 of the Federal Food, Drug, and Cos-13
metic Act (21 U.S.C. 360), as amended by sections 2 and 14
3 of this Act, is further amended by adding at the end 15
the following: 16
‘‘(t) I
NSTRUCTIONS FOR USE ANDVALIDATION 17
D
ATA.— 18
‘‘(1) I
NITIAL LIST.—Not later than 1 year after 19
the date of enactment of this subsection, the Sec-20
retary shall by regulation develop and publish a list 21
of types of rapid assessment tests described in sec-22
tion 201(h)(1)(D) for which reports under sub-23
section (k) must include— 24
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‘‘(A) instructions for use that have been 1
validated in a manner specified by the Sec-2
retary; and 3
‘‘(B) validation data, of the types specified 4
by the Secretary. 5
‘‘(2) U
PDATES.—The Secretary shall by regula-6
tion periodically update the list required by para-7
graph (1). 8
‘‘(3) E
NFORCEMENT.—Beginning on the date 9
of publication of the initial list under paragraph (1), 10
the Secretary shall not accept any notification under 11
subsection (k) for clearance of a type of rapid as-12
sessment test that is included on such list unless 13
such notification includes instructions for use and 14
validation data in accordance with paragraph (1).’’. 15
Æ
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