The US FDA and its Draft Guidance on Medical Device Appeals

On December 27, 2011, the Center for Devices and Radiological Health (CDRH) issued a draft guidance document on its appeals processes. On July 9, 2012, the Food and Drug Administration Safety and Innovation Act (FDASIA) became law, and put in place processes for medical device appeals not entirely consistent with the draft guidance. CDRH must assess the impact of FDASIA on the appeals guidance, and clarify key issues related to implementation of FDASIA.

This article was published in the April 2013 issue of Scrip Regulatory Affairs.