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Webinar Materials

• Presentation
• Printable Slides
• Transcript

Summary:

On October 15, 2020, the FDA hosted a webinar for the medical device industry and other stakeholders to discuss and answer questions about the final guidance Recognition and Withdrawal of Voluntary Consensus Standards.

Background:

On September 14, 2020, the FDA issued the final guidance: Recognition and Withdrawal of Voluntary Consensus Standards. This final guidance explains the updated procedures the FDA intends to follow when the FDA receives requests for recognition of consensus standards and withdraws recognition of a consensus standard.

In summary, the FDA:

• Will publish its justification for recognition and non-recognition decisions
• May, when appropriate, determine a transition time for revised standards
• Intends to respond to all recognition requests within 60 days
• Will periodically update the Recognized Standards Database with pending recognitions. As soon as FDA makes a determination to recognize a standard and it appears in the recognition database, manufacturers may cite them in premarket submissions; manufacturers will no longer have to wait for the publication of a Federal Register notice