FDA’s Mandate Gets More Complicated

Posted May 15, 2015 at 2:53pm

The Food and Drug Administration is tweaking the way it evaluates medical devices at a time when the agency finds itself at the center of a wide range of pressing health issues, from food safety to drug formulation and policing the pharmaceuticals supply chain.

The costs of regulatory oversight complicate any attempts to restructure the FDA’s processes. And the development of new technologies is blurring the lines of what the agency should regulate.

The FDA said in September 2014 it would not add new regulatory requirements for most smartphone medical applications. The agency instead is targeting the relatively small number of products that pose a greater risk to patients if they don’t work. Lawmakers, including Rep. Marsha Blackburn, R-Tenn., the vice chairwoman of the House Energy and Commerce Committee, have said the FDA’s role and authority in this arena should be more clearly defined to avoid regulatory overreach. A new law could make it easier for companies, especially small ones, to develop low-risk devices, some lawmakers have said.

The FDA’s top device regulator, Jeffrey E. Shuren, has argued such legislation might inadvertently stifle innovation in the medical mobile application marketplace, and prefers to the agency’s more flexible current approach.