FDA Issues Draft Guidance on Discontinuance or Interruption of Manufacturing of Certain Devices Implementing CARES Act
Arnold Porter
JANUARY 24, 2022
On January 10, 2022, the US Food and Drug Administration (FDA or Agency) published a new draft guidance (Draft Guidance) on manufacturer’s requirements to report certain medical device shortages. Introduction. This Draft Guidance, and the currently in place November 2020 Guidance, were prompted by shortages caused by the pandemic.
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