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FDA Will Fire Off Noncompliance Letters To Firms That Don’t Report Device Shortages, Agency Warns

Manufacturers must respond within 30 days

 
• By Shawn M. Schmitt

The US agency says in the latest update to its medical device shortages guidance doc that it’ll send enforcement missives to companies that don’t notify the agency of a “permanent discontinuance or an interruption in manufacturing” of products deemed critical during the COVID-19 pandemic.

Comic hand drawn illustration - mail delivery with flying letters.

Makers of medical devices deemed critical during the COVID-19 pandemic that fail to notify the US Food and Drug Administration of product shortages could find a letter of noncompliance from the agency in their mailbox.

That’s one of the messages in the latest update to the FDA’s device shortages guidance, a document that explains how manufacturers should comply with Sec. 506J of the Federal...

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