May 7, 2020

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

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.

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


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