A bill to strengthen medical device supply chains.
Bill: S.3834 | Sponsor: Sen. Braun, Mike (R-IN)
Policy area: Health

Summary:
This bill requires the Food and Drug Administration (FDA) to publish and periodically update a list of medical devices that are critical during a public health emergency and for which manufacturers must notify the FDA about shortages. The bill also requires manufacturers to develop risk management plans with respect to the supply chain for such devices.

To strengthen medical device supply chains.

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

SECTION 1. STRENGTHENING MEDICAL DEVICE SUPPLY CHAINS.

    (a) In General.--Section 506J of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 356j) is amended--
            (1) in the flush text at the end of subsection (a)--
                    (A) by inserting ``or of any other circumstance 
                that is likely to lead to a meaningful disruption in 
                the supply of the device or a shortage of the device, 
                and there is no other available device that could 
                reasonably be substituted for that device in the United 
                States'' before the period; and
                    (B) by adding at the end the following: ``The 
                Secretary shall develop and publish a list of device 
                product codes required to comply with this subsection, 
                and update the list every 3 years, or in response to a 
                public health emergency.'';
            (2) by redesignating subsections (h) and (i) as subsections 
        (j) and (k), respectively;
            (3) by inserting after subsection (g) the following:
    ``(h) Risk Management Plans.--Each manufacturer of a device that is 
included on the list 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. A risk management plan under this subsection--
            ``(1) may identify and evaluate risks to the supply of more 
        than one 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.'';
            (4) in subsection (f), by inserting ``or (i)'' after 
        ``subsection (a)''; and
            (5) by inserting after subsection (h), as added by 
        paragraph (3), the following:
    ``(i) Additional Notifications.--The Secretary may receive 
voluntary notifications from a manufacturer of a device that is life-
supporting, life-sustaining, or intended for use in emergency medical 
care or during surgery, or any other device the Secretary determines to 
be critical to the public health, pertaining to a permanent 
discontinuance in the manufacture of the device (except for any 
discontinuance as a result of an approved modification of the device) 
or an interruption of the manufacture of the device that is likely to 
lead to a meaningful disruption in the supply of that device in the 
United States, and the reasons for such discontinuance or 
interruption.''; and
            (6) in subsection (j) (as so redesignated by paragraph 
        (2))--
                    (A) by striking ``shall be construed to affect'' 
                and inserting the following: ``shall be construed--
            ``(1) to affect'';
                    (B) by striking the period at the end and inserting 
                ``; or''; and
                    (C) by adding at the end the following:
            ``(2) to grant the Secretary the authority to--
                    ``(A) require specific design, management, 
                implementation, or updating of risk management plans;
                    ``(B) assess performance or compliance with a risk 
                management plan, under subsection (h); or
                    ``(C) require notification under subsection (i).''.
    (b) Report.--Not later than 2 years after the date of enactment of 
this Act, and annually thereafter, the Secretary of Health and Human 
Services shall prepare and submit to the Committee on Health, 
Education, Labor, and Pensions of the Senate and the Committee on 
Energy and Commerce of the House of Representatives a report on the use 
of information manufacturers submit pursuant to section 506J of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356j) and applicable 
guidance issued with respect to such section, and any actions taken by 
the Secretary to mitigate or prevent a device shortage.
    (c) Guidance on Voluntary Notifications of Discontinuance or 
Interruption of Device Manufacture.--Not later than 1 year after the 
date of enactment of this Act, the Secretary shall issue draft guidance 
to facilitate voluntary notifications under subsection (i) of section 
506J of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356j), as 
added by subsection (a). Such guidance shall include a description of 
circumstances in which a voluntary notification under such subsection 
(i) may be appropriate, recommended timeframes within which sponsors 
may submit such a notification, the process for receiving such 
notifications, and actions the Secretary may take to mitigate or 
prevent a shortage resulting from a discontinuance or interruption in 
the manufacture of a device for which such notification is received. 
The Secretary shall issue final guidance not later than 1 year after 
the close of the comment period for the draft guidance.
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