Research Examines Characteristics of Pivotal Trials and FDA Review of Innovative Medical Devices

Patients with serious health conditions who lack sufficient treatment options often look to the U.S. Food and Drug Administration to promptly approve therapeutic alternatives, such as medical devices. Understanding how these innovative devices are developed and approved—including the lengths of premarket clinical trials and FDA review—can help identify ways to get such products to patients more quickly.

Research from The Pew Charitable Trusts, published Feb. 4 in PLOS ONE, examines several years of clinical trial and premarket FDA review data for innovative medical devices that fill unmet needs. The findings indicate that additional work is needed to shorten clinical trials for new products while still ensuring that high-quality data are obtained.

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