The 510k program is by far the most popular medical device pathway, and as MedTech has continued to modernize and innovate, so should the 510k program. Earlier this month, the FDA announced the steps it was taking to modernize the 510k program, a much sought after initiative that the industry has been asking for.
Over the past several years the FDA has slowly introduced programs to modernize the 510k. One of these programs was the FDA’s Safety and Performance Based Pathway, which was an expansion upon the concept of the Abbreviated 510k. The Safety and Performance Based Pathway allows manufacturers to utilize FDA-identified performance criteria to demonstrate safety and effectiveness of a device, which significantly reduced the evidence burden versus the other 510k pathways. Since 2019, the FDA has released 10 final device-specific guidance documents which identify the performance criteria for the specific devices, including spinal plating systems, fracture fixation plates, soft daily wear contact lenses, with many more on the way.
The next step in modernizing the pathway is the long-awaited eSTAR. Piloted in 2020, we are now only one month away from mandatory eSTAR submission. The eSTAR was a welcome initiative in the industry because it significantly modernized the approach to compiling a 510k. Instead of having to compile the 100’s of pages required in the eCopy format, in addition to mailing the submission to the FDA, the eSTAR made everything electronic and much more user friendly.
Finally, the FDA has announced three new draft guidance documents that are proposing more specific recommendations for how to select a predicate device, how to know when clinical data on substantial equivalence is necessary, and finally a guidance document on designing and executing performance testing and evidentiary requirements. These documents will harmonize the agency’s thoughts and recommendations on various universal components of compiling a 510k that will help industry.
We are excited to see the agency taking these steps to modernize the 510k program. These initiatives are arguably the largest and most concrete steps to improve the pathway since its inception nearly 50 years ago.
 FDA (March 2023) Safety and Performance Based Pathway retrieved on 09/12/2023 from: https://www.fda.gov/medical-devices/premarket-notification-510k/safety-and-performance-based-pathway