Is the 510(k) process as worthless as the federal courts seem to believe?

Does the Food and Drug Administration’s review of medical devices in the 510(k) program involve a substantial review of safety and effectiveness? The FDA says it does. Device makers and those of us who practice in this area know how burdensome and extensive this process can be.

It requires device makers to provide extensive preclinical safety and effectiveness data for the FDA’s review. Depending upon the type of device, FDA may also require clinical data. We wrote a Food and Drug Law Journal (FDLJ) article in 2014 describing the evolution of the 510(k) program and its current-day rigor.

Nonetheless, the federal courts continue to view the 510(k) process as a nothing-burger.