USA – FDA seeks comment on device shortage reporting guidance

The US Food and Drug Administration (FDA) on Monday released draft guidance on the new notification requirements for reporting medical device discontinuances and manufacturing interruptions created under the Coronavirus Aid, Relief, and Economic Security Act (CARES Act).

The CARES Act was signed into law in the early months of the COVID-19 pandemic and, for the first time, established requirements for medical device makers to notify FDA of permanent discontinuances or manufacturing interruptions that could lead to shortages of critical medical devices during or in advance of a public health emergency.

In May 2020, FDA issued an immediately effective guidance explaining those requirements in context of the COVID-19 pandemic, and in November 2020, the agency revised the guidance to provide further clarity on what factors it used to determine whether a device is in shortage. (RELATED: CDRH explains notification requirements for device shortages under CARES ActRegulatory Focus 6 May 2020; Device shortage guidance gets a COVID update from FDARegulatory Focus 2 December 2020)…