Sec. 516. Preventing medical device shortages
344 words·~2 min read·
/bill/117/s/3799/is/section-516A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
Section 506J of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 356j ), as amended by section 515, is further 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 there is no other available device that could reasonably be substituted for that device in the United States before the period; in subsection (f), by inserting or
(i)after subsection
(a); and by inserting after subsection (h), as added by section 515, the following: The Secretary may receive notifications from a manufacturers 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. . Not later than 1 year after the date of enactment of this Act, the Secretary shall issue draft guidance to facilitate voluntary notifications under subsection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 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 The Secretary shall issue final guidance not later than 1 year after the close of the comment period for the draft guidance.
Connectionstraces to 1
Traces to 1 document
Citation graph
cites case law
Sec. 516
Preventing medical device shortages
Cites 1Cited by 0 across 0 sources