510(k) Modernization 2023

On September 6, 2023, FDA announced its latest efforts to modernize the 510(k) process, outlining FDA’s latest improvements to strengthen the 510(k) Program and announcing release of three draft guidance documents.  This announcement addresses one of the commitments in FDA’s Medical Device Safety Action Plan: Protecting Patients, Promoting Public Health.

In the announcement, FDA highlights the Safety and Performance Based Pathway launched in 2019, which we blogged about here, noting that there are now ten device-specific final guidances allowing use of this pathway for clearance of the following device types:  Spinal Plating Systems, Orthopedic Non-Spinal Metallic Bone Screws and Washers, Magnetic Resonance Receive-Only Coils, Cutaneous Electrodes for Recording Purposes, Conventional Foley Catheters, Fracture Fixation Plates, Surgical Sutures, Denture Base Resin, Facet Screw Systems, and Soft (Hydrophilic) Daily Wear Contact Lenses.

The electronic Submission Template and Resource (eSTAR) program, which we blogged about here and here, also makes the highlight reel given its aim to improve consistency and efficiency in how 510(k)s are prepared.  Use of the eSTAR template for 510(k)s becomes mandatory on October 1, 2023 (unless exempt as described in the final guidance).

The biggest news in the announcement is the release of three draft guidance documents, which will be the subjects of future blog posts:

• 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

Finally, the announcement notes that FDA will be engaging with manufacturers that are marketing pre-amendment status devices to ensure that the preamendment status for these devices is still applicable.  As a reminder, devices with preamendment status are those that were legally marketed in the US before May 28, 1976, have not been significantly changed since May 28, 1976, and for which a regulation requiring a premarket approval application has not been published.

Over the years, we’ve blogged on similar initiatives related to the 510(k) pathway.  In 2010, the 510(k) Working Group and the Task Force on the Utilization of Science in Regulatory Decision Making each released a preliminary report with a series of recommendations for the 510(k) program, including development of guidance and regulation to provide greater assurance that any comparison of a new device to a predicate is valid and well-reasoned (link).  In 2011, the Institute of Medicine released a report recommending elimination of the 510(k) process altogether (link), noting an inherent conflict between the legislative framework and FDA’s stated goals to protect patients and promote innovation in support of public health. In a statement released at the time, CDRH Director Jeffrey Shuren, M.D., J.D., stated, “We appreciate the IOM’s report on the 510(k) program. . . . FDA believes that the 510(k) process should not be eliminated but we are open to additional proposals and approaches for continued improvement of our device review programs.” More recently, in 2019, FDA announced a push for predicate modernization (link) following a 2018 plan to modernize the 510(k) program by eliminating use of old predicates, sunsetting older predicates, and establishing the Safety and Performance Based Pathway (link).

Even with the rapid evolution of medical device technology, FDA’s 510(k) program remains the most commonly used device premarket pathway, making the need for clarity of requirements and predictability in submission review essential for sponsors.   We look forward to a deeper dive into the new draft guidance documents for better understanding of FDA’s current thinking on these long-time challenges related to the 510(k) program.