WHAT: CDRH 2016 Experiential Learning Program (ELP) to invite medical device industry, academia, and health care facilities to participate in training program for FDA’s medical device review staff
WHY: CDRH staff training to
- understand policies, laboratory practices, and challenges with device development life cycle
- enhance communication and facilitate the premarket review process.
- understand current industry practices, innovative technologies, regulatory impacts, and regulatory needs
NOT a compliance inspection
WHO: Medical device industry, academia, and health care facilities can participate
HOW: Submit electronic or written request for participation