Medical Device Shortage Reduction Act of 2023

Bill: 118-hr-3807
Sponsor: full_name: Rep. Castor, Kathy [D-FL-14]
Introduced: 2023-06-05
Policy area: Health
Subjects: Health technology, devices, supplies

Manufacturing

Strategic materials and reserves
Latest action: action_date: 2023-06-09
text: Referred to the Subcommittee on Health.

Summaries:
action_date: 2023-06-05
action_desc: Introduced in House
text: <p><strong>Medical Device Shortage Reduction Act of 2023</strong></p><p>This bill expands the scope of required notifications about medical device&nbsp;shortages beyond public health emergencies.</p><p>Currently, manufacturers of medical devices that are critical during a public health emergency (e.g., devices that are life-supporting, life-sustaining, or intended for use in emergency medical care or during surgery), or for which the Department of Health and Human Services (HHS) determines information about the supply chain is necessary during a public health emergency, must notify HHS of expected shortages of such devices. Manufacturers may voluntarily provide information on expected shortages of other critical medical devices, whether or not there is a public health emergency.</p><p>The bill expands these provisions so as to generally require manufacturers to notify HHS of expected shortages of critical medical devices, whether or not there is a public health emergency. It also requires manufacturers to develop risk management plans that identify potential risks to the supply chain of such devices.&nbsp;</p>

tv_txt: I 118th CONGRESS 1st Session H. R. 3807 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.

1. Short title This Act may be cited as the Medical Device Shortage Reduction Act of 2023 . 2. Clarifying device shortage notifications Section 506J(a) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 356j(a) ) is amended— (1) in paragraph (2), by striking during, or in advance of, a public health emergency ; and (2) in the matter following paragraph (2), by striking , during, or in advance of, a public health emergency declared by the Secretary under section 319 of the Public Health Service Act, . 3. Supply chain risk management (a) Section 506J of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 356j ) is amended by striking subsection (h) and inserting the following: (h) Risk management plans Each manufacturer of a device described in subsection (a) shall develop, maintain, and, as appropriate, implement a risk management plan that identifies and evaluates risks to the supply of the device, as applicable, for each establishment in which such device is manufactured. Such risk management plan— (1) may identify and evaluate risks to the supply of more than 1 device, or device category, manufactured at the same establishment; and (2) shall be subject to inspection and copying by the Secretary pursuant to section 704 or at the request of the Secretary. . (b) Conforming amendment Section 506J(f) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 356j(f) ) is amended by striking or (h) after subsection (a) . 4. Clarifying voluntary notifications Section 506J(i) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 356j(i) ) is amended by adding at the end the following: Nothing in this section shall be construed to limit the authority of the Secretary to request that a manufacturer (or other person involved in the device supply chain) provide, on a voluntary basis, information to the Secretary or the authority of the Secretary to receive such information. .