The U.S. Food and Drug Administration (FDA) issued the immediately in effect guidance Notifying CDRH of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act During the COVID-19 Public Health Emergency. The FDA is issuing this guidance to implement section 506J of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 351 et seq.), as added by section 3121 of the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), as it relates to device shortages and potential device shortages occurring during the COVID-19 pandemic, for the duration of the COVID-19 public health emergency.
READ THE GUIDANCE »
Facts about the guidance
Manufacturers of devices that are critical to public health during a public health emergency, or for which the FDA determines information on potential meaningful supply disruptions is needed during a public health emergency (described in Section III of the guidance) are required to notify the FDA of an interruption or permanent discontinuance in manufacturing of such devices by Section 506J of the FD&C Act. The guidance:
Upcoming webinar on this guidance
On May 11, 2020, the FDA will host a webinar for medical device manufacturers and others interested in learning more about the guidance.
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