FDA Releases Draft Guidances on 510(k) Submissions

| Paige L. Cappelli

On September 6, 2023, the U.S. Food & Drug Administration (FDA) released three draft guidance documents to provide updated recommendations on the 510(k) Program to “keep pace with the increasing complexity of rapidly evolving technology.” As stated on the FDA website: “[E]ach person who wants to market in the U.S., a Class I, II, and III device intended for human use, for which a Premarket Approval application (PMA) is not required, must submit a 510(k) to FDA unless” the device meets certain limited exemptions. A 510(k) submission provides, for the FDA’s review, safety and effectiveness data to show that a new device is substantially equivalent to a legally marketed predicate device. The FDA has been modernizing the 510(k) Program over the years to keep up with the advancement in technology. The three draft guidances released on September 6, 2023 were informed by the FDA’s 2019 request for public feedback.

The three draft guidance documents are as follows:

(1) Best Practices for Selecting a Predicate Device to Support a Premark Notification [510(k)] Submission (linked here).

(2) Recommendations for the Use of Clinical Data in Premarket Notification [510(k)] Submissions (linked here).

(3) Evidentiary Expectations for 510(k) Implant Devices (linked here).

The first draft guidance proposes best practice factors for selecting a predicate device. The recommendation includes to select a valid predicate device that: (1) “was cleared using well-established methods,” (2) “continues to perform safely and as intended,” (3) “does not have unmitigated use-related or design-related safety issues,” and (4) “has not been subject to a design-related recall.”

The second draft guidance clarifies, with specific examples, situations when clinical data may or may not be needed to support a 510(k) submission. The draft guidance explores four scenarios where clinical data may be necessary: (1) differences in the indications for use, (2) differences in the technological characteristics, (3) when substantial equivalence cannot be determined by non-clinical testing, and (4) newly identified or increased risk for the predicate device.

The third draft guidance provides more details relating to evidentiary requirements for implanted devices. The draft guidance recommends considering the following factors when preparing evidence and information to support a 510(k) submission for an implant: (1) the indications for use, (2), the intended duration of the implant in the body, and (3) the anticipated patient and physician experience with the implant.

The FDA is seeking public comments on these draft guidances through December 6, 2023.