May 7, 2020

FDA issues guidance to prevent device shortages during COVID-19 pandemic

By: Judy Mathias

Editor's Note

The Food & Drug Administration (FDA) on May 6 issued a guidance to implement section 3121 of the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) as it relates to shortages and potential shortages of medical devices occurring during the COVID-19 pandemic.

Manufacturers are required to notify the FDA of a permanent discontinuance or significant interruption in the manufacturing of certain medical devices to prevent or mitigate shortages of these devices during the COVID-19 public health emergency.

Sponsored Message

The guidance also clarifies and makes recommendations on who must notify the FDA and how, and what information to include in the notification.


Sign Up For OR a.m.
Sign up for the free OR a.m. eLetter to get news like this in your inbox every morning!

OR Manager Jobs
Live chat by BoldChat