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Webinar Materials

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Summary: On October 31, 2019, the U.S. Food and Drug Administration (FDA) will host a webinar for device manufacturers and industry to discuss and answer questions about the Special 510(k) Program Final Guidance.

Background: On September 12, 2019, the FDA issued a final guidance document on the Special 510(k) Program.

"The New 510(k) Paradigm: Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications" guidance is superseded by this final guidance document and The Abbreviated 510(k) Program, which reflects the Abbreviated 510(k) information from the New 510(k) Paradigm guidance.

The FDA also updated the following final guidance documents to reflect the updated Special 510(k) Program, improve alignment between the related 510(k) guidance, and reflect current policies:

• Format for Traditional and Abbreviated (510(k)s)
• Refuse to Accept Policy for 510(k)s

Together, these guidance documents provide consistency, clarity and transparency to industry and the FDA and may conserve resources for both, while still protecting public health, and not altering the statutory criteria for substantial equivalence.