Please note this is an extract of the original bulletin.
FDA Issues Guidance and Requests Comments as a Part of Ongoing Efforts to Modernize the Premarket Notification [510(k)] Program
To modernize the 510(k) Program to improve the safety of medical devices, the U.S. Food and Drug Administration (FDA) issued the following three draft guidance intended to support efforts to continue to strengthen and modernize the 510(k) Program and advance the safety and effectiveness of medical devices as they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
These guidance are open for comments until December 6, 2023.
Additionally, as part of the FDA’s efforts to modernize the 510(k) Program and implement Medical Device User Fee Amendments 2022 (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. More information on this can be found here.
On October 26, 2023, the FDA will host a webinar for industry and other stakeholders interested in learning more about these draft guidance and the FDA’s ongoing efforts to modernize the 510(k) Program.
If you have specific questions about the draft guidance and the webinar, please contact the 510(k) Program.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