Us Congress 2025-2026 Regular Session

Us Congress House Bill HB2372 Compare Versions

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Old	New	Differences
1	1	I
2	2	119THCONGRESS
3	3	1
4	4	STSESSION H. R. 2372
5	5	To amend the Federal Food, Drug, and Cosmetic Act to enhance medical
6	6	device communications and ensure device cleanliness.
7	7	IN THE HOUSE OF REPRESENTATIVES
8	8	MARCH26, 2025
9	9	Mr. L
10	10	IEU(for himself, Ms. CHU, and Ms. NORTON) introduced the following
11	11	bill; which was referred to the Committee on Energy and Commerce
12	12	A BILL
13	13	To amend the Federal Food, Drug, and Cosmetic Act to
14	14	enhance medical device communications and ensure de-
15	15	vice cleanliness.
16	16	Be it enacted by the Senate and House of Representa-1
17	17	tives of the United States of America in Congress assembled, 2
18	18	SECTION 1. SHORT TITLE. 3
19	19	This Act may be cited as the ‘‘Disclosure; and En-4
20	20	couragement of Verification, Innovation, Cleaning, and 5
21	21	Efficiency Act of 2025’’ or the ‘‘DEVICE Act of 2025’’. 6
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24	24	•HR 2372 IH
25	25	SEC. 2. REPORTING REQUIREMENT FOR DESIGN AND RE-1
26	26	PROCESSING INSTRUCTION CHANGES. 2
27	27	(a) A
28	28	DULTERATION.—Section 501 of the Federal 3
29	29	Food, Drug, and Cosmetic Act (21 U.S.C. 351) is amend-4
30	30	ed by inserting after paragraph (j) the following: 5
31	31	‘‘(k) If it is a device with respect to which the manu-6
32	32	facturer is in violation of the reporting requirement under 7
33	33	section 510(r) (relating to design and reprocessing 8
34	34	changes).’’. 9
35	35	(b) R
36	36	EQUIREMENT.—Section 510 of the Federal 10
37	37	Food, Drug, and Cosmetic Act (21 U.S.C. 360) is amend-11
38	38	ed by adding at the end the following: 12
39	39	‘‘(r) R
40	40	EPORTINGREQUIREMENT FOR DEVICEDE-13
41	41	SIGNCHANGES.—Before making a change to the design 14
42	42	of a device, or the reprocessing instructions of a device, 15
43	43	that is marketed in interstate commerce, the manufacturer 16
44	44	of the device shall give written notice of the change to 17
45	45	the Secretary.’’. 18
46	46	SEC. 3. REPORTING REQUIREMENT FOR CERTAIN COMMU-19
47	47	NICATIONS TO FOREIGN HEALTH CARE PRO-20
48	48	VIDERS. 21
49	49	(a) A
50	50	DULTERATION.—Section 501 of the Federal 22
51	51	Food, Drug, and Cosmetic Act (21 U.S.C. 351), as 23
52	52	amended by section 2 of this Act, is further amended by 24
53	53	inserting after paragraph (k) the following: 25
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56	56	•HR 2372 IH
57	57	‘‘(l) If it is a device with respect to which the manu-1
58	58	facturer is in violation of the reporting requirement under 2
59	59	section 510(s) (relating to communications to foreign 3
60	60	health care providers).’’. 4
61	61	(b) R
62	62	EQUIREMENT.—Section 510 of the Federal 5
63	63	Food, Drug, and Cosmetic Act (21 U.S.C. 360), as 6
64	64	amended by section 2 of this Act, is further amended by 7
65	65	adding at the end the following: 8
66	66	‘‘(s) R
67	67	EPORTINGREQUIREMENT FOR CERTAINCOM-9
68	68	MUNICATIONS TOFOREIGNHEALTHCAREPROVIDERS.— 10
69	69	‘‘(1) R
70	70	EQUIREMENT.—The manufacturer of a 11
71	71	device that is marketed in interstate commerce shall 12
72	72	give written notice to the Secretary of any commu-13
73	73	nication described in paragraph (2) not more than 14
74	74	5 calendar days after making such communication. 15
75	75	‘‘(2) C
76	76	OMMUNICATION DESCRIBED .—A commu-16
77	77	nication is described in this paragraph if the com-17
78	78	munication— 18
79	79	‘‘(A) is made by the manufacturer of the 19
80	80	device or an affiliate of the manufacturer; 20
81	81	‘‘(B) relates to a change to the design of 21
82	82	the device, a change to the recommended re-22
83	83	processing protocols, if any, for the device, or a 23
84	84	safety concern about the device; and 24
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87	87	•HR 2372 IH
88	88	‘‘(C) is widely disseminated (including on a 1
89	89	voluntary basis) to health care providers in a 2
90	90	foreign country. 3
91	91	‘‘(3) A
92	92	FFILIATE.—In this subsection, the term 4
93	93	‘affiliate’ means a business entity that has a rela-5
94	94	tionship with a second business entity if, directly or 6
95	95	indirectly— 7
96	96	‘‘(A) one business entity controls, or has 8
97	97	the power to control, the other business entity; 9
98	98	or 10
99	99	‘‘(B) a third party controls, or has the 11
100	100	power to control, both of the business entities.’’. 12
101	101	SEC. 4. RAPID ASSESSMENT TESTS INTENDED TO ENSURE 13
102	102	PROPER REPROCESSING. 14
103	103	(a) I
104	104	NCLUSION IN DEVICEDEFINITION.—Section 15
105	105	201 of the Federal Food, Drug, and Cosmetic Act (21 16
106	106	U.S.C. 321) is amended— 17
107	107	(1) in paragraph (h)(1)— 18
108	108	(A) in clause (B), by striking ‘‘or’’ at the 19
109	109	end; 20
110	110	(B) in clause (C), by striking ‘‘and’’ at the 21
111	111	end and inserting ‘‘or’’; and 22
112	112	(C) by inserting after clause (C) the fol-23
113	113	lowing: 24
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116	116	•HR 2372 IH
117	117	‘‘(D) a rapid assessment test intended to ensure the 1
118	118	proper reprocessing of a reusable device (as defined in 2
119	119	paragraph (tt)), and’’; and 3
120	120	(2) by adding at the end the following: 4
121	121	‘‘(tt) The term ‘reusable device’ means a device 5
122	122	that— 6
123	123	‘‘(1) is intended to be used more than one time; 7
124	124	and 8
125	125	‘‘(2) must be sanitized (whether through clean-9
126	126	ing, disinfection, or sterilization) to ensure that the 10
127	127	device is safe and effective for such intended use.’’. 11
128	128	(b) I
129	129	NSTRUCTIONS FOR USE AND VALIDATION 12
130	130	D
131	131	ATA.—Section 510 of the Federal Food, Drug, and Cos-13
132	132	metic Act (21 U.S.C. 360), as amended by sections 2 and 14
133	133	3 of this Act, is further amended by adding at the end 15
134	134	the following: 16
135	135	‘‘(t) I
136	136	NSTRUCTIONS FOR USE ANDVALIDATION 17
137	137	D
138	138	ATA.— 18
139	139	‘‘(1) I
140	140	NITIAL LIST.—Not later than 1 year after 19
141	141	the date of enactment of this subsection, the Sec-20
142	142	retary shall by regulation develop and publish a list 21
143	143	of types of rapid assessment tests described in sec-22
144	144	tion 201(h)(1)(D) for which reports under sub-23
145	145	section (k) must include— 24
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148	148	•HR 2372 IH
149	149	‘‘(A) instructions for use that have been 1
150	150	validated in a manner specified by the Sec-2
151	151	retary; and 3
152	152	‘‘(B) validation data, of the types specified 4
153	153	by the Secretary. 5
154	154	‘‘(2) U
155	155	PDATES.—The Secretary shall by regula-6
156	156	tion periodically update the list required by para-7
157	157	graph (1). 8
158	158	‘‘(3) E
159	159	NFORCEMENT.—Beginning on the date 9
160	160	of publication of the initial list under paragraph (1), 10
161	161	the Secretary shall not accept any notification under 11
162	162	subsection (k) for clearance of a type of rapid as-12
163	163	sessment test that is included on such list unless 13
164	164	such notification includes instructions for use and 14
165	165	validation data in accordance with paragraph (1).’’. 15
166	166	Æ
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