FDA: Final Guidance Will Help Device Makers Comply With Reporting Mandates To Mitigate Shortages

Agency Also Says That Manufacturers May Submit Voluntary Notifications of Supply Chain Issues Anytime
Dennis Tosh
December 14, 2023 at 09:19 AM EST
Newly finalized guidance from the FDA should help device manufacturers provide “timely, informative notifications about changes in the production of certain medical device products that will help prevent or mitigate shortages,” the agency says. The guidance, “Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&... Read More

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