Strategic Application Of Regulatory Pathways For Medical Devices

By Evan L. Rosenfeld, MD, JD, FCLM, Vice President of Medical and Scientific Affairs, Medical Device and Diagnostics, Theorem Clinical Research

The Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA) signed into law by President Obama last July is a sweeping piece of legislation that, among many other provisions, enacts reforms aimed at improving various FDA regulatory procedures, including the medical device review and approval processes.

How FDASIA may affect manufacturers of medical devices depends on a number of factors, including the risk/reward ratio and the size of the target population that stands to benefit from market approval of the device. To understand the impact of the new legislation, a quick review of the existing regulatory landscape for medical devices is in order.