Frederick J. Schoen, M.D., Ph.D., Executive Vice Chairman of the Department of Pathology at Brigham and Women’s Hospital, will discuss regulatory essentials in medical device and diagnostics development for clinical translation at this Molecular Robotics Initiative meeting at the Wyss Institute.
This presentation will provide an overview of regulatory considerations in the context of therapeutic medical device and diagnostic test development. Although the emphasis will be on FDA requirements for device and test approval (managed collectively by the FDA Center for Devices and Radiological Health), related strategic issues related to clinical implementation of drugs, devices and biologics also will be discussed.
The slides from this presentation are available to download: Regulatory Essentials in Medical Device and Diagnostics Development for Clinical Translation
Should you repurpose the content of this presentation, please appropriately attribute to Frederick J. Schoen, MD/PhD, Brigham and Women’s Hospital, Boston.