Recognition and Withdrawal of Voluntary Consensus Standards; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of the draft guidance entitled ``Recognition and Withdrawal of Voluntary Consensus Standards.'' This draft guidance identifies the principles FDA uses for recognizing a standard, and it explains the extent of recognition and other supplementary information. It provides information on how you may request recognition as well as circumstances under which FDA may withdraw recognition. This draft guidance also responds to a provision of the 21st Century Cures Act (Cures Act) by updating published guidance on these topics. This draft guidance is not final nor is it in effect at this time.