FDA issues policy for manufacturers to prevent medical device shortages

The Food and Drug Administration today issued guidance implementing section 3121 of the Coronavirus Aid, Relief, and Economic Security Act, which requires manufacturers to notify FDA of a permanent discontinuance or significant interruption in the manufacture of certain medical devices to prevent or mitigate shortages during the COVID-19 emergency.

FDA said the guidance aims to clarify and make recommendations regarding who must notify FDA and how, and what information to include in the notification.