The U.S. Food and Drug Administration (FDA) has published an updated list of recognized consensus standards that can used in support of premarket medical device reviews conducted by the agency.
Published in the U.S. Federal Register, the extensive list includes updated information on standards that have been withdrawn, modified or replaced since the last published list, as well as additional standards not previously recognized by the FDA. The standards list is organized by the standard’s medical or functional focus to help device manufacturers quickly identify the standards relevant to their specific device.
Evidence of compliance with the technical requirements of FDA-recognized consensus standards can be used to demonstrate compliance with certain FDA requirements applicable to medical devices. The use of recognized consensus standards can speed the pre-review testing and assessment of new or modified medical devices and can help facilitate the premarket review process by FDA reviewers.