Understanding when and how to communicate directly with the FDA is crucial in speeding a medical device application to market. This special workshop, offered in collaboration with Biologics Consulting Group (BCG), takes you step-by-step through the maze of the medical device pre-approval process and highlights how to effectively communicate with FDA decision makers throughout. Explore important features of a high-quality Pre-IDE submission, the most common reasons for IDE disapproval, and determine when a panel meeting is necessary. Through the use of real world case studies the course discusses what really matters to FDA in determining 510(k) versus a PMA, clinical study considerations, and the unique focus of FDA medical device Bioresearch Monitoring inspections. This workshop will include a discussion of combination products including jurisdictional issues and common problems to avoid.
The lead instructor is a past medical reviewer at the FDA Center for Devices and Radiological Health and was an agency leader in developing the multi-center review practices for evaluating drug-eluting stents and other combination products.
To learn more about BCG, visit www.biologicsconsulting.com.
Familiarity with the pathway of medical devices to market. Completion of "Regulation of Medical Devices and Diagnostics," "Medical Devices: Regulatory Strategies and Pathways to Market," or equivalent experience.
