HealthIT Answers March 28, 2021
By Jeff Shuren, M.D., J.D., Director, Center for Devices and Radiological Health (CDRH), and Daniel Caños, Ph.D., M.P.H., Director, Office of Clinical Evidence and Analysis, Office of Product Evaluation and Quality, CDRH, FDA
Among the many ways that the U.S. Food and Drug Administration protects and promotes the public health is by ensuring the safety and effectiveness of medical devices, assuring that patients have timely access to them, and advancing medical device innovation. For sponsors of medical products, providing data from prospective randomized controlled trials has long been considered the gold standard to demonstrate the safety and efficacy of a regulated product. However, for many medical devices, practical limitations related to the device or disease condition require alternative approaches to...
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