FDA Releases 3 New Draft Guidances Regarding 510(k) Processes as Part of Modernization Efforts

Blog RSS

09/13/2023

Photo by Ross Findon on Unsplash

Guest blogger McKenna Fuller

On September 6, 2023 the US Food and Drug Administration (FDA) issued a bulletin announcing three new draft guidances regarding the FDA’s Center for Devices and Radiological Health’s (CDRH) 510(k) premarket submission program to verify that the medical device to be marketed is substantially equivalent to a legally marketed device as medical devices continue to become more complex and innovative. The three new draft guidances are:

• 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

The first draft guidance “Best Practices for Selecting a Predicate” is to assist device manufacturers with selecting a predicate device and recommends a description in the 510(k) Summary section of how best practices were used to select the predicate device. This guidance intends to promote transparency to the public regarding the process.

The second draft guidance, “Clinical Data in 510(k)s”, helps submitters by providing clarity on when clinical data is necessary to be provided in the 510(k) submission. For example, innovation of materials or newly identified risks in the predicate device that creates a difference in the current safety profile, clinical data for the same type of device may be requested.

The third draft guidance, “Evidentiary Expectations for Implants” provides updated recommendations for manufacturers on the design and execution of appropriate performance testing for 510(k) implant devices, as well as the appropriate content and labeling information to include in 510(k) submissions for those devices.

Jeff Shuren, director of FDA’s CDRH, said in a statement alongside the announcement, "We intend to finalize these three guidances and use other opportunities to continue to strengthen and modernize other aspects of the 510(k) Program to help deliver safe, effective and high-quality medical devices to patients.” For the past ten years, the CDRH has been making implementations to modernize current processes. Issuing these draft guidances signifies that ongoing commitment.

To leave comments on the new draft guidances follow the links below for each docket number:

• 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

All comments for consideration are due by December 6, 2023.

For more information on these newly issued draft guidances the FDA will host a webinar for industry and other stakeholders on October 26, 2023.

- The Clinical Pathways Team

Enjoy this blog? Please like, comment, and share with your contacts.