Devices

3 New 510(k) Guidances

FDA has published three draft guidances that, when finalized, will provide updated recommendations on specific aspects of the medical device 510(k) program. An online 510(k) update (contains links to the new guidances) says the drafts are “informed by a 2019 request for public feedback to continue to modernize the 510(k) program while promoting patient safety.”

The first first guidance is Best Practices for Selecting a Predicate Device to Support a Premarket Notification [510(k)] Submission. FDA says the factors include that the predicate device (1) was cleared using well-established methods; (2) meets or exceeds expected safety and performance; (3) does not have unmitigated use-related or design-related safety issues; and (4) is not associated with a design-related recall. The agency says it believes that using the best practices outlined in the draft will encourage the evolution of safer and more effective medical devices in the 510(k) program over time.

The second guidance is Recommendations for the Use of Clinical Data in Premarket Notification [510(k)] Submissions. FDA says this guidance provides transparency on when the agency recommends manufacturers submit clinical data in their 510(k) submission. Specifically, it clarifies certain situations when clinical data may or may not be needed to support a 510(k) submission. FDA says that when the guidance is finalized, it will enhance predictability, consistency, and transparency in using clinical data.

The third guidance is Evidentiary Exceptions for 510(k) Implant Devices. The agency says this draft is expected to enhance predictability for sponsors in preparing 510(k) submissions for implants and promote consistency in reviewing implants through the 510(k) program.

The update also says that as of 10/1, all 510(k) submissions, unless exempted, must be submitted as electronic submissions using eSTAR. It further says that the agency is working with manufacturers that are marketing devices that have been listed with a pre-amendment status to ensure that the status is still applicable for devices currently marketed.

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