Today, the U.S. Food and Drug Administration (FDA) issued this draft guidance: Notifying the FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act.
This draft guidance, when finalized, is intended to:
Read the draft guidance
This draft guidance is not intended to supersede the COVID-19 Public Health Emergency Guidance, “Notifying CDRH of a Permanent Discontinuance or Interruption in Manufacturing of a Device under 506J of the FD&C Act during the COVID-19 Public Health Emergency,” which will be withdrawn at the end of the COVID-19 Public Health Emergency.
Note: This draft guidance is not for implementation at this time.
This draft guidance will be open for public comments for 60 days at www.regulations.gov under docket number FDA-2022-D-0053.
The FDA invites comments on the draft guidance, in general, and on the following questions, in particular:
For questions about this document regarding CDRH-regulated devices, contact CDRHManufacturerShortage@fda.hhs.gov.
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