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Q&A: Harvard Professor Talks JAMA Study That Looks At 45 Years Of FDA Premarket Data

 
• By Shawn M. Schmitt

The study concludes that the regulatory process has become complex and the path to market for some medical devices tricky.

Interview

A study recently published in the Journal of the American Medical Association (JAMA) reviewed trends in US premarket review pathways for medtech products from 1976 to 2020 and concluded that the regulatory process has become complex and the path to market for some medical devices tricky.

“Increased [Food and Drug Administration] support from industry and concern about flexible authorization requirements reflect the tension between efficient access and the need for assurances that products will safely benefit patients,”

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