FDA Lecture: Regulatory Science in CDRH’s Office of Science and Engineering Laboratories
2 Koret Way, San Francisco, CA 94131
Christopher Scully, PhD
Research Biomedical Engineer, Office of Science and Engineering Laboratories
Center for Devices and Radiological Health
U.S. Food and Drug Administration
The Office of Science and Engineering Laboratories (OSEL) serves as the research arm of the Center for Devices and Radiological Health (CDRH), US Food and Drug Administration. Regulatory science performed in OSEL supports the assessment of the enormous breadth of devices that CDRH regulates from MRI scanners and neural stimulation devices to pacemakers, cancer treatments and other lifesaving products. In this talk, we will first outline the role regulatory science plays to support CDRH’s mission and provide an overview of the research performed in OSEL. Then, we will discuss regulatory science challenges and research needs to support medical device development towards future integrated clinical environments. We will highlight research in OSEL related to data-driven, multi-parameter monitoring systems and physiologic closed-loop control systems.
Christopher Scully is a Research Biomedical Engineer at FDA in the Center for Devices and Radiological Health / Office of Science and Engineering Laboratories. He leads and performs research in the areas of 1) computational and bench testing of physiological monitors and closed-loop controlled medical devices and 2) methods to test performance of medical device alarm systems that use advanced signal processing and machine learning. Dr. Scully provides technical regulatory and policy support in the areas of physiologic signal processing, machine learning in patient monitoring systems, and physiologic closed-loop control technology. Dr. Scully received his Ph.D. in Biomedical Engineering from Worcester Polytechnic Institute.