Mon.Jan 24, 2022

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FDA Issues Draft Guidance on Discontinuance or Interruption of Manufacturing of Certain Devices Implementing CARES Act

Arnold Porter

The new Draft Guidance follows prior FDA guidance on notifying the Agency of a permanent discontinuation or interruption in manufacturing of a device during the COVID-19 public health emergency, last updated in November 2020 (November 2020 Guidance).[[N: FDA is accepting public comments on the Draft Guidance through March 14, 2022.

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