COVID-19 News, ADMINISTRATION OF FDC ACT—FDA GUIDANCE NOTICES: Draft guidance for notification of discontinuing or interrupting device manufacture, (Jan 11, 2022)

By Kristofer Ray, PhD

Guidance should serve as a baseline for implementing recent amendments to the Food, Drug, and Cosmetic Act (FD&C Act) as it relates to device shortages during (or in advance of) a public health emergency.

The FDA has released a draft guidance to assist manufacturers in notifying the agency either of permanent discontinuations or ...