FDA Issues Three New Draft Guidances on the 510(k) Program
On September 6, the FDA published three new draft guidances as part of its efforts to modernize the 510(k) Program with the goal of improving the safety of medical devices while continuing to bring critical devices to patients. The new guidances include:
- 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
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. Stakeholders are also encouraged to submit comments to the FDA on the draft guidances by December 6, 2023.
Starting October 1, 2023, all 510(k) submissions, unless exempted, must be submitted as electronic submissions using eSTAR. Join us on September 21, 2023 for “Crossing the eSTAR Chasm: Transitioning to FDA’s Mandatory 510k eSTAR Submission Process” to learn more about the submission process. This webinar will be available on demand as well.
Related Articles
-
Beginning October 1, 2023, the FDA’s Total Product Life Cycle Advisory Program (TAP) Pilot will expand to include the Office of Neurological and Physical Medicine Devices (OHT5).
-
The draft guidance covers DCT design, informed consent, the use of remote clinical trial visits, safety monitoring and software used in conducting DCTs for drugs, biological products, and devices. The comment period is open until August 1, 2023.
-
Effective February 7, the agency will conduct inspections across all commodities, as well as mission-critical foreign and domestic inspections.
-
The CERSI program was established to foster robust and innovative approaches to advance regulatory science through collaborative interactions with FDA scientific experts.
