Getting your medical device cleared for marketing in the U.S

This discussion group will explore the different requirements for getting a medical device cleared for marketing in the United States. Specifically, the discussion leaders will give an overview of the 510(k) and PMA, registration, and listing processes. The discussion will also include what is required for foreign companies who wish to import medical devices. The discussion group leaders include Robert Munzner, a former branch chief for the Office of Device Evaluation at the FDA, and Grace Bartoo, a regulatory consultant with over 20 years in the imedical device industry. The format of this session is a discussion group, so please bring your questions and experiences to share.