II 

117TH CONGRESS 

2D SESSION S. 3834 

To strengthen medical device supply chains. 

IN THE SENATE OF THE UNITED STATES 

MARCH 14, 2022 

Mr. BRAUN (for himself and Mr. MARSHALL) introduced the following bill; 

which was read twice and referred to the Committee on Health, Education, Labor, and Pensions 

A BILL 

To strengthen medical device supply chains. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. STRENGTHENING MEDICAL DEVICE SUPPLY 

4 CHAINS. 

5 (a) IN GENERAL.—Section 506J of the Federal 

6 Food, Drug, and Cosmetic Act (21 U.S.C. 356j) is amend7 ed— 

8 (1) in the flush text at the end of subsection 

9 (a)— 

10 (A) by inserting ‘‘or of any other cir11 cumstance that is likely to lead to a meaningful 


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1 disruption in the supply of the device or a 

2 shortage of the device, and there is no other 

3 available device that could reasonably be sub4 stituted for that device in the United States’’ 

5 before the period; and 

6 (B) by adding at the end the following: 

7 ‘‘The Secretary shall develop and publish a list 

8 of device product codes required to comply with 

9 this subsection, and update the list every 3 

10 years, or in response to a public health emer11 gency.’’; 

12 (2) by redesignating subsections (h) and (i) as 

13 subsections (j) and (k), respectively; 

14 (3) by inserting after subsection (g) the fol15 lowing: 

16 ‘‘(h) RISK MANAGEMENT PLANS.—Each manufac17 turer of a device that is included on the list described in 

18 subsection (a), shall develop, maintain, and, as appro19 priate, implement a risk management plan that identifies 

20 and evaluates risks to the supply of the device, as applica21 ble, for each establishment in which such device is manu22 factured. A risk management plan under this subsection— 

23 ‘‘(1) may identify and evaluate risks to the sup24 ply of more than one device, or device category, 

25 manufactured at the same establishment; and 


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1 ‘‘(2) shall be subject to inspection and copying 

2 by the Secretary pursuant to section 704 or at the 

3 request of the Secretary.’’; 

4 (4) in subsection (f), by inserting ‘‘or (i)’’ after 

5 ‘‘subsection (a)’’; and 

6 (5) by inserting after subsection (h), as added 

7 by paragraph (3), the following: 

8 ‘‘(i) ADDITIONAL NOTIFICATIONS.—The Secretary 

9 may receive voluntary notifications from a manufacturer 

10 of a device that is life-supporting, life-sustaining, or in11 tended for use in emergency medical care or during sur12 gery, or any other device the Secretary determines to be 

13 critical to the public health, pertaining to a permanent dis14 continuance in the manufacture of the device (except for 

15 any discontinuance as a result of an approved modification 

16 of the device) or an interruption of the manufacture of 

17 the device that is likely to lead to a meaningful disruption 

18 in the supply of that device in the United States, and the 

19 reasons for such discontinuance or interruption.’’; and 

20 (6) in subsection (j) (as so redesignated by 

21 paragraph (2))— 

22 (A) by striking ‘‘shall be construed to af23 fect’’ and inserting the following: ‘‘shall be con24 strued— 

25 ‘‘(1) to affect’’; 


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1 (B) by striking the period at the end and 

2 inserting ‘‘; or’’; and 

3 (C) by adding at the end the following: 

4 ‘‘(2) to grant the Secretary the authority to— 

5 ‘‘(A) require specific design, management, 

6 implementation, or updating of risk manage7 ment plans; 

8 ‘‘(B) assess performance or compliance 

9 with a risk management plan, under subsection 

10 (h); or 

11 ‘‘(C) require notification under subsection 

12 (i).’’. 

13 (b) REPORT.—Not later than 2 years after the date 

14 of enactment of this Act, and annually thereafter, the Sec15 retary of Health and Human Services shall prepare and 

16 submit to the Committee on Health, Education, Labor, 

17 and Pensions of the Senate and the Committee on Energy 

18 and Commerce of the House of Representatives a report 

19 on the use of information manufacturers submit pursuant 

20 to section 506J of the Federal Food, Drug, and Cosmetic 

21 Act (21 U.S.C. 356j) and applicable guidance issued with 

22 respect to such section, and any actions taken by the Sec23 retary to mitigate or prevent a device shortage. 

24 (c) GUIDANCE ON VOLUNTARY NOTIFICATIONS OF

25 DISCONTINUANCE OR INTERRUPTION OF DEVICE MANUVerDate Sep 11 2014 02:13 Mar 16, 2022 Jkt 029200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\S3834.IS S3834

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1 FACTURE.—Not later than 1 year after the date of enact2 ment of this Act, the Secretary shall issue draft guidance 

3 to facilitate voluntary notifications under subsection (i) of 

4 section 506J of the Federal Food, Drug, and Cosmetic 

5 Act (21 U.S.C. 356j), as added by subsection (a). Such 

6 guidance shall include a description of circumstances in 

7 which a voluntary notification under such subsection (i) 

8 may be appropriate, recommended timeframes within 

9 which sponsors may submit such a notification, the proc10 ess for receiving such notifications, and actions the Sec11 retary may take to mitigate or prevent a shortage result12 ing from a discontinuance or interruption in the manufac13 ture of a device for which such notification is received. 

14 The Secretary shall issue final guidance not later than 1 

15 year after the close of the comment period for the draft 

16 guidance. 

Æ 


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