FDA's Refreshed Approach To Device Safety Would Require Major Changes To 510(K) Program

On November 26, 2018, FDA Commissioner Scott Gottlieb and device center director Jeff Shuren issued a statement outlining a plan to modernize the 510(k) premarket review program to bolster medical device safety. The 510(k) program relies on a device being compared to a legally marketed predicate device; i.e., a similar device that was already determined to be legally marketable. Most devices come to market through the 510(k) pathway.

FDA's announcement contains three key points.

FDA wants device manufacturers to use more modern predicate devices or objective performance criteria when they seek clearance of their 510(k). According to FDA, nearly 20% of current 510(k)s are cleared based on a predicate that's more than 10 years old. FDA suggests that means some devices are not continually improving, but is it the role of FDA to encourage such improvement and are more modern predicates needed in every situation? The agency is taking a forward-leaning approach rather than playing the part of a passive regulator, which should be understood alongside recent news that portrays FDA as too slow to respond to safety issues. But there may be reasons to use an older predicate that have nothing to do with safety, such as when a type of device does not evolve quickly.

FDA is considering publicizing devices that were cleared based on comparison to a predicate that is more than 10 years old. FDA would seek public comment on this approach, including if other criteria should be considered and if there are other ways to promote the use of more modern predicates. Despite FDA's repeated statement that relying on an old predicate does not mean a device is unsafe, this seems like an obvious attempt to publicly shame companies into using more modern predicates by creating an impression that there is something wrong with devices that were cleared based on older predicates (otherwise, a layperson may reasonably ask, why publish a list of them?). This is an interesting approach for two FDA leaders—Drs. Gottlieb and Shuren—who, based on my experience working with them, favor market-based approaches rather than government intervention. That is, if patients and doctors prefer devices based on more modern predicates, the market for devices based on old predicates will dwindle. Drs. Gottlieb and Shuren would likely respond by saying this is a small nudge to the market to improve conditions, necessary especially because of the potential benefits for patient safety.

FDA...