Device 510(k) modernization: Three draft guidances from CDRH

Since at least 2010, FDA has been focused on “modernizing” the 510(k) process. As part of its recent Safety Action Plan (2018), FDA’s Center for Devices and Radiological Health (CDRH) committed to modernizing its 510(k) Premarket Notification program by improving clarity, predictability, and consistency. On September 6, 2023, CDRH released a set of three draft guidance documents to further support this effort. These documents provide greater insight into the center’s thinking in the areas of predicate selection, 510(k) clinical data, and expectations for implants.

• 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

Selecting a predicate

Identifying the most appropriate predicate to compare a new device to is a critical element of the 510(K) marketing authorization pathway. Selecting the right predicate helps minimize the issue of predicate creep, where devices with slightly different technological characteristics or indications are cleared and, over time, newer devices are less and less equivalent to the original predicate. Through the draft guidance titled Best Practices for Selecting a Predicate Device to Support a Premarket Notification [510(k)] Submission, CDRH seeks to improve this problem by suggesting four “best practices” to consider when selecting a predicate.

Specifically, FDA elaborates on selecting predicates with the following characteristics:

• Predicates that were cleared using well-established methods
• Predicates that have met or exceeded safety and performance expectations
• Predicates that do not have unmitigated use-related or design-related safety issues
• Predicates that do not have an associated design-related recall

Importantly for companies planning to submit a 510(k) in the future, the guidance also recommends explaining in the 510(k) Summary how these four best practices were considered during predicate selection.

Clinical data in 510(k)s

While clinical data is often not necessary to support 510(k) clearance, CDRH will require it in certain cases to demonstrate substantial equivalence. The draft guidance titled Recommendations for the Use of Clinical Data in Premarket Notification [510(k)] Submissions seeks to help companies understand when FDA will expect clinical data as part of a 510(k). The guidance walks through four example scenarios in which clinical data may be needed:

• Differences in indications for use
• Differences in technological characteristics
• Substantial equivalence cannot be determined by non-clinical testing alone
• A new or increased risk has since been identified with the predicate device

Expectations for implants

The third draft guidance released by CDRH is titled Evidentiary Expectations for 510(k) Implant Devices, and covers recommendations generally relevant to all types of implants subject to the 510(k) marketing clearance pathway. Through this guidance, the center provides insight into its expectations for a variety of areas, such as necessary performance testing, labeling content, and identification and mitigation of risks unique to implants. CDRH makes a point to explain that while these recommendations help support demonstration of substantial equivalence in a 510(k) submission, many of the recommendations (such as mitigation of risks) go beyond the pre-market stage and would be valuable to continue to consider for implantable devices once on the market.

Impact and next steps

These three draft guidance documents represent an important step forward for CDRH in modernizing the 510(k) program and continue a decades long effort to streamline the 510(k) program, with clarity on safety and submissions processes and clarity on predicate expectations. Of note, the current modernization efforts differ from those undertake thirteen years ago in that the foundational structure of the 510(k) program and the statutory framework for “substantial equivalence” are not being reconsidered and rather the focus is on clarity and implementation improvements. On October 26, 2023, CDRH will hold a public webinar to further assist understanding and adoption of the recommendations outlined in these guidances. In addition, CDRH is requesting feedback on these draft guidance documents and comments for each can be submitted here:

• 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

For more information on adapting to this evolving regulatory landscape, please contact your DLA Piper relationship partner, the authors of this alert, or any member of our FDA practice.