FDA Update

Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act Final Guidance

The U.S. Food and Drug Administration’s Center for Devices and Radiological Health’s new presentation, Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act Final Guidance, is now available online. This presentation provides a background on Section 506J and discusses CDRH’s role in medical device supply chain and shortages. It also covers the 506J Device List and FDA’s ability to receive additional voluntary notifications outside of a public health emergency.

The presentation, printable slides, and transcript are available now on CDRH Learn under “Postmarket Activities,” sub-section “General Policy.”

Questions?

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If you have any questions on this Policy please let us know,
info@mdiconsultants.com and ref: 506J