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FDA Issues Guidances and Requests Comments as a Part of Ongoing Efforts to Modernize the Premarket Notification [510(k)] Program

We recognize there is a need to continue to modernize the 510(k) Program to improve the safety of medical devices while continuing to bring critical devices to patients. Today, the U.S. Food and Drug Administration (FDA) issued the following three draft guidances intended to support efforts to continue to strengthen and modernize the 510(k) Program and advance the safety and effectiveness of medical devices as they become more complex and innovative:

• Best Practices for Selecting a Predicate Device to Support a Premarket Notification [510(k)] Submission
• Recommendations for the Use of Clinical Data in Premarket Notification [510(k)] Submissions
• Evidentiary Expectations for 510(k) Implant Devices

Issuing these draft guidances marks an important step in the FDA’s Center for Devices and Radiological Health’s ongoing commitment to optimize the clarity, predictability, and consistency of the 510(k) Program as we implement the Medical Device User Fee Amendments 2022 (MDUFA V).

Additionally, as part of the FDA’s efforts to modernize the 510(k) Program and implement MDUFA V, starting October 1, 2023, all 510(k) submissions, unless exempted, must be submitted as electronic submissions using eSTAR, as noted in the Electronic Submission Template for Medical Device 510(k) Submissions final guidance. eSTAR is the only available electronic submission template to facilitate the preparation of 510(k) electronic submissions. Read more about how the FDA continues to modernize the 510(k) Program in our update, FDA Continues to Take Steps to Strengthen the Premarket Notification [510(k)] Program, and other new information available on the FDA’s website:

• Medical Device Safety and the 510(k) Clearance Process
• Total Product Life Cycle for Medical Devices
• 510(k) Clearances

Request for comments

Submit comments under the appropriate docket number listed below at www.regulations.gov by December 6, 2023, to ensure the FDA considers your comments on the draft guidances before it begins work on the final versions of the guidances.

• Best Practices for Selecting a Predicate: FDA-2023-D-3134
• Clinical Data in 510(k)s: FDA-2023-D-3133
• Evidentiary Expectations for Implants: FDA-2023-D-3132

Upcoming webinar on these guidances

On October 26, 2023, the FDA will host a webinar for industry and other stakeholders interested in learning more about these draft guidances and the FDA's ongoing efforts to modernize the 510(k) Program.

Questions?

If you have specific questions about the draft guidances and the webinar, please contact the 510(k) Program. If you have general questions about the 510(k) Program, please contact the Division of Industry and Consumer Education.