Medical Device Shortage Reduction Act of 2023

Medical Device Shortage Reduction Act of 2023

This bill expands the scope of required notifications about medical device shortages beyond public health emergencies.

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.

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. 

[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3807 Introduced in House (IH)]

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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 Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Medical Device Shortage Reduction 
Act of 2023''.

SEC. 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,''.

SEC. 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)''.

SEC. 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.''.
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