Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices; Guidance for Industry and Food and Drug Administration Staff; Availability

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ``Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices.'' Voluntary consensus standards can be a valuable resource for industry and FDA staff because such standards can increase predictability, streamline premarket review, provide clearer regulatory expectations, and facilitate market entry for safe and effective medical products. FDA developed this document to provide guidance to industry and FDA reviewers about the appropriate use of voluntary consensus standards in the preparation and evaluation of premarket submissions for medical devices. This guidance applies to all articles that meet the definition of a ``device'' under the Federal Food, Drug, and Cosmetic Act (FD&C Act).