FDA May Move to Tighten Approval Process for Medical Devices

The FDA has been criticized in recent years for fast tracking approvals for medical devices that ultimately failed and had to be recalled or revised. In response to the criticism, the federal agency has issued a 120 page proposal outlining tougher rules for devices attempting to gain the FDA’s approval. The new proposals come after the FDA was critical of its own procedures after admitting to bowing to outside pressure from medical device companies to approve medical devices in a quicker fashion. The flash point revolves around the FDA’s controversial approval of ReGen Biologics Inc. (RGBO) knee device the prior year.
The new proposals are designed to deal with issues concerning the agency 510(k) application process. According to the Wall St. Journal, ” To access the 510(k) pathway, companies must show there is an already approved device similar to their new product; this was a big point of controversy in the ReGen case. The FDA, in its new proposal, recommended developing guidance to clarify when devices shouldn’t be used as a benchmark. The agency is still working on these definitions, and wants help from public comments, but pointed to evidence of confusion about the rules.
The FDA also wants to clarify its authority to rescind prior device approval, which has only been done about 100 times since 510(k) rules were created more than 30 years ago, officials noted.
Additionally, the agency proposed creating a subset of “Class II” devices, which are generally devices considered a moderate risk to patients, for which clinical or manufacturing data would be needed to bolster the case they are substantially equivalent to an already-approved product. Shuren said drug infusion pumps, which are ubiquitous hospital products the FDA is seeking to improve amid a history of problems, fall into this new “Class IIb” category.”