II 

117TH CONGRESS 

2D SESSION S. 3477 

To improve the program for reporting on device shortages. 

IN THE SENATE OF THE UNITED STATES 

JANUARY 11 (legislative day, JANUARY 10), 2022 

Mr. CASEY (for himself and Ms. COLLINS) introduced the following bill; which 

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

Labor, and Pensions 

A BILL 

To improve the program for reporting on device shortages. 

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

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Planning, Reporting, 

5 and Enabling Voluntary Expansion of Notifications Tar6 geting Medical Device Shortages Act of 2022’’ or the 

7 ‘‘PREVENT Medical Device Shortages Act of 2022’’. 

8 SEC. 2. PREVENTING MEDICAL DEVICE SHORTAGES. 

9 (a) NOTIFICATIONS.— 


pbinns on DSKJLVW7X2PROD with BILLS
2 

•S 3477 IS

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

2 Food, Drug, and Cosmetic Act (21 U.S.C. 356j) is 

3 amended— 

4 (A) in the flush text at the end of sub5 section (a), by inserting ‘‘or of any other cir6 cumstance that is likely to lead to a meaningful 

7 disruption in the supply of the device or a 

8 shortage of the device and other devices that 

9 could reasonably be substituted for that device 

10 in the United States’’ before the period; 

11 (B) in subsection (f), by inserting ‘‘or (h)’’ 

12 after ‘‘subsection (a)’’; 

13 (C) by redesignating subsections (h) and 

14 (i) as subsections (j) and (k), respectively; and 

15 (D) by inserting after subsection (g) the 

16 following: 

17 ‘‘(h) ADDITIONAL NOTIFICATIONS.—The Secretary 

18 may receive notifications from a manufacturer of a device 

19 that is life-supporting, life-sustaining, or intended for use 

20 in emergency medical care or during surgery, or any other 

21 device the Secretary determines to be critical to the public 

22 health, pertaining to a permanent discontinuance in the 

23 manufacture of the device (except for any discontinuance 

24 as a result of an approved modification of the device) or 

25 an interruption of the manufacture of the device that is 


pbinns on DSKJLVW7X2PROD with BILLS
3 

•S 3477 IS

1 likely to lead to a meaningful disruption in the supply of 

2 that device in the United States, and the reasons for such 

3 discontinuance or interruption. 

4 ‘‘(i) RISK MANAGEMENT PLANS.—Each manufac5 turer of a device that is critical to the public health, in6 cluding devices that are life-supporting, life-sustaining, or 

7 intended for use in emergency medical care or during sur8 gery, shall develop, maintain, and, as appropriate, imple9 ment a redundancy risk management plan that identifies 

10 and evaluates risks to the supply of the device, as applica11 ble, for each establishment in which such device is manu12 factured. A risk management plan under this subsection— 

13 ‘‘(1) may identify and evaluate risks to the sup14 ply of more than 1 device manufactured at the same 

15 establishment; and 

16 ‘‘(2) shall be subject to inspection and copying, 

17 both remotely and physically, by the Secretary pur18 suant to section 704 or at the request of the Sec19 retary.’’. 

20 (2) REPORT.—Not later than 1 year after the 

21 date of enactment of this Act, and annually for 4 

22 years thereafter, the Secretary of Health and 

23 Human Services (referred to in this section as the 

24 ‘‘Secretary’’) shall prepare and submit to the Com25 mittee on Health, Education, Labor, and Pensions 


pbinns on DSKJLVW7X2PROD with BILLS
4 

•S 3477 IS

1 of the Senate and the Committee on Energy and 

2 Commerce of the House of Representatives a report 

3 on the use of information manufacturers submit pur4 suant to section 506J of the Federal Food, Drug, 

5 and Cosmetic Act (21 U.S.C. 356j) or applicable 

6 guidance. 

7 (3) GUIDANCE ON VOLUNTARY NOTIFICATIONS

8 OF DISCONTINUANCE OR INTERRUPTION OF DEVICE

9 MANUFACTURE.—Not later than 1 year after the 

10 date of enactment of this Act, the Secretary shall 

11 issue draft guidance to facilitate voluntary notifica12 tions under subsection (h) of section 506J of the 

13 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

14 356j), as added by paragraph (1). Such guidance 

15 shall include a description of circumstances in which 

16 a voluntary notification under such subsection (h) 

17 may be appropriate, recommended timeframes within 

18 which sponsors should submit such a notification, 

19 the process for receiving such notifications, and ac20 tions the Secretary may take to mitigate or prevent 

21 a shortage resulting from a discontinuance or inter22 ruption in the manufacture of a device for which 

23 such notification is received. The Secretary shall 


pbinns on DSKJLVW7X2PROD with BILLS
5 

•S 3477 IS

1 issue final guidance not later than 1 year after the 

2 close of the comment period for the draft guidance. 

Æ 


pbinns on DSKJLVW7X2PROD with BILLS