CDRH Industry Update: Overview of Medical Device Classification and Reclassification

On July 9, 2012, Congress enacted the Food and Drug Administration Safety and Innovation Act (FDASIA).  Section 608(c) of FDASIA requires the FDA to annually post the number and type of medical devices reclassified in the previous calendar year. In response to this requirement, the FDA created a new web page that provides an overview of the medical device classification and reclassification processes and includes links to tables that give details about the medical devices reclassified by the FDA each year.  In addition, FDA updated several related web pages, including 515 Project Status and Evaluation of Automatic Class III Designation (De Novo) Summaries.