16 March 2021 - Among the many ways that the U.S. FDA 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 randomised 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 prospective randomised controlled trials and increased flexibility in trial design and statistical analysis.

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