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FDA Issues Three New Draft Guidances on the 510(k) Program

By MedTech Intelligence Staff
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The FDA has issued three new draft guidances related to the 510(k) submissions program, including Best Practices for Selecting a Predicate Device, Use of Clinical Data in Premarket Notification and Evidentiary Expectations for Implant Devices. The agency is accepting comments and will host a webinar for stakeholders on October 26, 2023, to provide more information on the guidances.

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:

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.



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