Webinar Reminder: Final Guidance for Special Premarket Notification [510(k)] Pathway

On September 12, 2019, the U.S. Food and Drug Administration (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510(k) Paradigm: Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications” guidance is superseded by this final guidance document and The Abbreviated 510(k) Program, which reflects the Abbreviated 510(k) information from the New 510(k) Paradigm guidance.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.

For More Information

• Webinar: On October 31, 2019 at 1:00 PM EDT, the FDA will host a webinar to discuss these guidances.
• Learn More: Device Advice: Premarket Notification 510(k)
• Questions: If you have questions, please contact the Division of Industry and Consumer Education (DICE) in the Center for Devices and Radiological Health at 1-800-638-2014, 301-796-7100 or Dice@fda.hhs.gov.