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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

Executive Summary

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.

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