Virtual imaging perspectives from the FDA
Date: 03/18/2022 12-1 PM Eastern time
Speakers: Andreu Badal, Ph.D., FDA
Medical imaging systems and image analysis or processing software commercialized in the United States require pre-marketing authorization by the Food and Drug Administration’s Center for Devices and Radiological Health (FDA/CDRH). Dr. Badal introduces the basic mechanisms that the FDA uses for regulatory evaluation of medical devices and reviews existing guidance documents intended to assist in the reporting of computational modeling and simulation studies and the assessment of their credibility in regulatory submissions. Dr. Badal also presents current and potential applications of virtual imaging in the regulatory framework and highlights regulatory science research projects under way at CDRH’s Office of Science and Engineering Laboratories (OSEL) that aim to increase the use of modeling in regulatory reviews. Finally, an overview of the Medical Device Development Tools (MDDT) program is presented. MDDTs provide a practical mechanism for CDRH to evaluate and qualify the quality of a proposed tool (such as a virtual imaging simulator or anatomical phantom) for a specific context of use, thus reducing the regulatory burden and uncertainty in subsequent device submissions using this tool.