FDA Issues New Draft Guidance on How Medical Device Manufacturers Should Warn of Potential Shortages

The FDA has proposed new guidelines for medical device manufacturers, outlining how the industry should alert the agency when there may be a shortage or interruption for key products or supplies.

A draft guidance was issued on Monday, focusing on notification requirements involving medical device interruptions and device discontinuances, that would significantly affect critical supplies of medical devices in the United States.

The federal regulators are specifically calling on manufacturers to let them know when they believe the supply of that device will be interrupted during or in advance of a public health emergency.

The draft guidance falls under the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), which was signed into law during the early months of the COVID-19 pandemic. It established requirements for medical device manufacturers and called on them to notify the FDA of permanent discontinuances of devices or manufacturing interruptions that could lead to meaningful shortages of critical supplies during a public health emergency.

The FDA proposes how these requirements should be acted upon by medical device manufacturers during and beyond the COVID-19 pandemic.

As part of the announcement, the FDA also published a list of medical devices that are currently in shortage or have been discontinued, which affected the general public during the pandemic. The list includes items such as personal protective equipment, gloves and surgical gowns, laboratory reagents, testing supplies, specimen collection, swabbing supplies, and ventilators and related products.

According to the draft guidance, manufacturers should voluntarily provide details to ensure shortages can be prevented or the impact on public health can be reduced during emergency situations that go beyond COVID-19 pandemic scenarios. The guidance will not supersede the COVID-19 emergency guidance, should it be approved before the pandemic ends.

“This guidance is intended to assist manufacturers in providing timely, informative notifications about changes in the production of certain medical device products that will help prevent or mitigate shortages of such devices,” FDA officials wrote.

Public comments on the draft guidance will be accepted until March 11, 2022. Comments can be submitted online, or by mail to Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

All written comments must be identified with docket number FDA-2022-D-0053.