Risk-Benefit Guidance Aims To Improve Pre-Market Review Predictability
This article was originally published in The Gray Sheet
Executive SummaryIt takes more than safety and effectiveness data alone for FDA device reviewers to determine how benefits stack up against risks in a pre-market submission, the agency accentuates in new draft guidance.
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Device center reviewers will begin applying the guidance to incoming PMA and de novo submissions and to submissions already under review with decisions beginning on May 1.
A planned survey evaluating obese patients’ tolerance for risk fits into a broader initiative by CDRH to reassess, and in some cases rebalance, how it weighs risks and benefits when making regulatory decisions.
Decision analysis tools will be put into practice as part of the device center’s priority “innovation pathway” for breakthrough devices and in a pilot program focused on obesity devices. The techniques may allow for shorter development and review cycles, among other benefits, CDRH says.