II
117th CONGRESS
2d Session
S. 3477
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.
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
.
Preventing medical device shortages
Notifications
In general
Section 506J of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356j) is amended—
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;
in subsection (f), by inserting or (h)
after subsection (a)
;
by redesignating subsections (h) and (i) as subsections (j) and (k), respectively; and
by inserting after subsection (g) the following:
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.
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—
may identify and evaluate risks to the supply of more than 1 device manufactured at the same establishment; and
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.
.
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.
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.