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Medical Devices / Regulatory Affairs

FDA Revises List of Recognized Consensus Standards

Oct. 30, 2018

CDRH has revised its list of recognized consensus standards for medical devices and in vitro diagnostics.

The move comes on the heels of guidance issued last month explaining how the FDA implements its program that allows it to recognize consensus standards developed by international and national organizations in satisfying portions of premarket review submissions.

In an Oct. 22 notice, the agency described the addition, withdrawal and revision of close to 90 FDA-recognized standards. The draft guidance will assist devicemakers who elect to declare conformity with consensus standards.

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