Title: PREVENT Medical Device Shortages Act of 2022
Policy area: Health

Summary:
Planning, Reporting, and Enabling Voluntary Expansion of Notifications Targeting Medical Device Shortages Act of 2022 or the PREVENT Medical Device Shortages Act of 2022
This bill expands existing requirements for manufacturers of certain medical devices to alert the Food and Drug Administration (FDA) of supply disruptions and addresses related issues.
Under this bill, a manufacturer of a medical device that is critical to public health during a declared public health emergency must notify the FDA as soon as practicable of any circumstance that is likely to lead to a meaningful disruption to the supply of the device in the United States. Currently, the manufacturer is only required to notify the FDA of supply disruptions stemming from manufacturing issues.
The bill also authorizes the FDA to receive notifications from manufacturers of medical devices that are critical to public health about manufacturing issues that are likely to lead to a meaningful disruption to the U.S. supply of the device.
Each manufacturer of a medical device that is critical to the public health must develop and implement a redundancy risk management plan in each manufacturing facility for the device. Such a plan shall be subject to FDA inspection.

[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[S. 3477 Introduced in Senate (IS)]

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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.

    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 ``Planning, Reporting, and Enabling 
Voluntary Expansion of Notifications Targeting Medical Device Shortages 
Act of 2022'' or the ``PREVENT Medical Device Shortages Act of 2022''.

SEC. 2. PREVENTING MEDICAL DEVICE SHORTAGES.

    (a) Notifications.--
            (1) In general.--Section 506J of the Federal Food, Drug, 
        and Cosmetic Act (21 U.S.C. 356j) is amended--
                    (A) in the flush text at the end of subsection (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 other 
                devices that could reasonably be substituted for that 
                device in the United States'' before the period;
                    (B) in subsection (f), by inserting ``or (h)'' 
                after ``subsection (a)'';
                    (C) by redesignating subsections (h) and (i) as 
                subsections (j) and (k), respectively; and
                    (D) by inserting after subsection (g) the 
                following:
    ``(h) Additional Notifications.--The Secretary may receive 
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.
    ``(i) Risk Management Plans.--Each manufacturer of a device that is 
critical to the public health, including devices that are life-
supporting, life-sustaining, or intended for use in emergency medical 
care or during surgery, shall develop, maintain, and, as appropriate, 
implement a redundancy 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 1 device manufactured at the same establishment; and
            ``(2) shall be subject to inspection and copying, both 
        remotely and physically, by the Secretary pursuant to section 
        704 or at the request of the Secretary.''.
            (2) Report.--Not later than 1 year after the date of 
        enactment of this Act, and annually for 4 years thereafter, the 
        Secretary of Health and Human Services (referred to in this 
        section as the ``Secretary'') 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) or applicable 
        guidance.
            (3) 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 (h) of section 506J of the Federal Food, Drug, 
        and Cosmetic Act (21 U.S.C. 356j), as added by paragraph (1). 
        Such guidance shall include a description of circumstances in 
        which a voluntary notification under such subsection (h) may be 
        appropriate, recommended timeframes within which sponsors 
        should 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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