Back to: FDA Regulatory Education for Industry (REdI) 2024 Conference – Devices Track
Presenter
Edward Margerrison, PhD
Director
Office of Science and Engineering Laboratories (OSEL)
Center for Devices and Radiological Health (CDRH)
U.S. Food and Drug Administration (FDA)
Ed Margerrison is the Director of CDRH’s Office of Science and Engineering Laboratories (OSEL) at the U.S. Food and Drug Administration. The Office is responsible for providing technical expertise and analyses in support of the regulatory processes within CDRH. Previously, he was President and CEO of Ortho Regenerative Technologies, a biotech startup focused on developing novel biomaterial approaches to surgical soft tissue repair. Dr. Margerrison has held senior positions at Zimmer Biomet, Akela Pharma and Smith and Nephew. He graduated in Biochemistry from the University of Oxford and gained his PhD in Molecular Genetics from St. George’s Hospital Medical School in London UK.
Abstract
Edward Margerrison from CDRH’s Office of Science and Engineering Lab (OSEL) discusses Regulatory Science Tools (RSTs) designed to enhance efficiency and drive innovation across the medical device product lifecycle. OSEL develops various tools, including laboratory methods, computer models, data sets for AI training, and phantoms. All OSEL RSTs are publicly available and aim to standardize approaches for evaluating device safety and effectiveness, making the review process easier for FDA reviewers and less burdensome for innovators. While helpful, RSTs are entirely voluntary for use in submissions and do not guarantee device clearance or approval. They differ from Medical Device Development Tools (MDDTs), which are qualified for a specific Context of Use and offer more certainty of acceptance within that context. Innovators can access these tools through the online catalog and explore OSEL’s program areas for potential development topics on the CDRH public access webpage.