This month, the U.S. Food and Drug Administration (FDA), finalized guidance requiring manufacturers to notify them of discontinuations or meaningful interruptions in manufacturing for many devices during or in advance of a public health emergency (PHE).
This relatively new authority was established through the 2020 CARES Act and amended by the 2023 Omnibus Consolidated Appropriations Act, altering 21 US Code 356J. This is intended to help prevent or mitigate potential shortages by allowing the FDA to have the appropriate knowledge to consider prioritizing and expediting inspections and premarket reviews to help mitigate shortages.
US FDA Rules for Notification of Discontinuation or Meaningful Interruption in Manufacturing
The U.S. Food & Drug Administration has finalized guidance requiring manufacturers to notify it of discontinuations or meaningful interruptions in manufacturing for many devices during, or in advance of, a public health emergency.
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