US Food and Drug Administration (FDA) regulators are calling for more guidance before implementing an internal working group’s recommendation to overhaul the approval process of medical devices.

The sweeping changes, recommended by the FDA’s Center for Devices and Radiological Health 510k working group last August, included mandates for additional clinical data for a new class of ‘medium-risk’ devices and post-approval surveillance of certain devices.

FDA officials yesterday announced that some of the recommendations would be implemented next March, including initiatives to streamline the approval of low-risk medical devices, but the agency plans to hold off on the most dramatic changes until an external panel convened by the US Institute of Medicine issues its recommendations, expected later this year.

The decision comes just days after Joshua Sharfstein, who led efforts at the FDA to toughen regulation of the medical device industry, stepped down as the agency’s deputy commissioner. In 2008, Sharfstein spearheaded an investigation into the FDA-approved knee replacement device Menaflex, manufactured by New Jersey-based ReGen Biologics, which ultimately resulted in the device being pulled off of medical supply store shelves.

The FDA announcement to hold off on major reforms is welcome news for medical device manufacturers, which are wary of further regulatory oversight and additional clinical work. Indeed, according to a PricewaterhouseCoopers report, medical device manufacturers are increasingly introducing their devices first overseas, presumably to dodge the FDA regulatory process.

Image by FitzColinGerald, Wikimedia