Medical Device Shortage Reduction Act of 2023

I 118TH CONGRESS 1ST SESSION H. R. 3807 To amend the Federal Food, Drug, and Cosmetic Act with respect to device shortage notifications. IN THE HOUSE OF REPRESENTATIVES JUNE 5, 2023 Ms. CASTOR of Florida 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 with respect to device shortage notifications. 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 ‘‘Medical Device Short- 4 age Reduction Act of 2023’’. 5 SEC. 2. CLARIFYING DEVICE SHORTAGE NOTIFICATIONS. 6 Section 506J(a) of the Federal Food, Drug, and Cos- 7 metic Act (21 U.S.C. 356j(a)) is amended— 8 (1) in paragraph (2), by striking ‘‘during, or in 9 advance of, a public health emergency’’; and 10 VerDate Sep 11 2014 05:08 Jun 28, 2023 Jkt 039200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H3807.IH H3807 kjohnson on DSK79L0C42PROD with BILLS 2 •HR 3807 IH (2) in the matter following paragraph (2), by 1 striking ‘‘, during, or in advance of, a public health 2 emergency declared by the Secretary under section 3 319 of the Public Health Service Act,’’. 4 SEC. 3. SUPPLY CHAIN RISK MANAGEMENT. 5 (a) Section 506J of the Federal Food, Drug, and 6 Cosmetic Act (21 U.S.C. 356j) is amended by striking 7 subsection (h) and inserting the following: 8 ‘‘(h) RISK MANAGEMENT PLANS.—Each manufac- 9 turer of a device described in subsection (a) shall develop, 10 maintain, and, as appropriate, implement a risk manage- 11 ment plan that identifies and evaluates risks to the supply 12 of the device, as applicable, for each establishment in 13 which such device is manufactured. Such risk management 14 plan— 15 ‘‘(1) may identify and evaluate risks to the sup- 16 ply of more than 1 device, or device category, manu- 17 factured at the same establishment; and 18 ‘‘(2) shall be subject to inspection and copying 19 by the Secretary pursuant to section 704 or at the 20 request of the Secretary.’’. 21 (b) CONFORMING AMENDMENT.—Section 506J(f) of 22 the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 23 356j(f)) is amended by striking ‘‘or (h)’’ after ‘‘subsection 24 (a)’’. 25 VerDate Sep 11 2014 05:08 Jun 28, 2023 Jkt 039200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H3807.IH H3807 kjohnson on DSK79L0C42PROD with BILLS 3 •HR 3807 IH SEC. 4. CLARIFYING VOLUNTARY NOTIFICATIONS. 1 Section 506J(i) of the Federal Food, Drug, and Cos- 2 metic Act (21 U.S.C. 356j(i)) is amended by adding at 3 the end the following: ‘‘Nothing in this section shall be 4 construed to limit the authority of the Secretary to request 5 that a manufacturer (or other person involved in the de- 6 vice supply chain) provide, on a voluntary basis, informa- 7 tion to the Secretary or the authority of the Secretary to 8 receive such information.’’. 9 Æ VerDate Sep 11 2014 05:08 Jun 28, 2023 Jkt 039200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6301 E:\BILLS\H3807.IH H3807 kjohnson on DSK79L0C42PROD with BILLS