FDA In Brief: FDA announces pilot program to increase consistency and predictability in premarket reviews of medical devices that use certain FDA-recognized consensus standards

FDA In Brief: FDA announces pilot program to increase consistency and predictability in premarket reviews of medical devices that use certain FDA-recognized consensus standards

Today the U.S. Food and Drug Administration issued a draft guidance outlining the goals and implementation of a new voluntary conformity assessment initiative, the Accreditation Scheme for Conformity Assessment (ASCA) Pilot, designed to promote consistency and predictability in the premarket review process for medical devices, encourage effective use of FDA resources, and enhance regulatory efficiency, while also enhancing confidence in medical device testing. Under the ASCA Pilot, the FDA would recognize qualified accreditation bodies who would accredit testing laboratories using ASCA program specifications associated with eligible consensus standards included in the Pilot. Consensus standards are frequently used by manufacturers to demonstrate that their devices meet safety and effectiveness expectations. Accredited in-house and independent laboratories, used by ...

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