Updated Guidance: Notifying CDRH Under Section 506J During the COVID-19 Public Health Emergency
Today, the U.S. Food and Drug Administration (FDA) updated the guidance, Notifying CDRH of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act During the COVID-19 Public Health Emergency.
The update is intended to further assist manufacturers in providing the FDA with timely and informative notifications about changes in the production of certain medical devices that could help the FDA prevent or mitigate shortages of such devices during the COVID-19 public health emergency. The FDA updated this guidance to:
- Clarify factors the FDA considers in determining:
- whether a device is in shortage,
- how shortage assessments inform FDA work to help address the public health emergency, and
- what information the FDA includes in the publicly-available list of medical devices the FDA has determined to be in shortage;
- Provide information regarding letters for failure to notify the FDA pursuant to section 506J(e) of the FD&C Act;
- Provide information about prioritizing and expediting inspections and premarket reviews to help mitigate and prevent shortages; and
- Revise the recommended timeline for updates to 506J notifications from two weeks to six weeks.
Questions?
If manufacturers have questions about this guidance, email CDRHManufacturerShortage@fda.hhs.gov and please begin the email subject line with the word "Question" to expedite our response.
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