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# Guidance on Device Consensus Standards
- URL: https://www.fdaweb.com/guidance-on-device-consensus-standards/
- Published: 2020-09-14T12:00:00.000Z
- Updated: 2026-09-14T16:28:35.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5147640

FDA has published a final guidance entitled *Recognition and Withdrawal of Voluntary Consensus Standards*. The document outlines principles for recognizing a standard wholly, partly, or not at all, as well as reasons and rationales for withdrawing a standard. According to the guidance, FDA: 

- Will publish its justification for recognition and non-recognition decisions
- May, when appropriate, determine a transition time for revised standards
- Intends to respond to all recognition requests within 60 days
- Will periodically update the [Recognized Standards Database](https://lnks.gd/l/eyJhbGciOiJIUzI1NiJ9.eyJidWxsZXRpbl9saW5rX2lkIjoxMDMsInVyaSI6ImJwMjpjbGljayIsImJ1bGxldGluX2lkIjoiMjAyMDA5MTQuMjcwNjEyMjEiLCJ1cmwiOiJodHRwczovL3d3dy5hY2Nlc3NkYXRhLmZkYS5nb3Yvc2NyaXB0cy9jZHJoL2NmZG9jcy9jZlN0YW5kYXJkcy9zZWFyY2guY2ZtP3V0bV9tZWRpdW09ZW1haWwmdXRtX3NvdXJjZT1nb3ZkZWxpdmVyeSJ9.M9IMgfgb72vyWw9wA8WFWsy0OkPyC5CY7omR8fbFLAo/s/1255931999/br/84846532637-l?ref=fdaweb.com) with pending recognitions.

Additionally, the agency has planned a 10/15 [Webinar](https://lnks.gd/l/eyJhbGciOiJIUzI1NiJ9.eyJidWxsZXRpbl9saW5rX2lkIjoxMDQsInVyaSI6ImJwMjpjbGljayIsImJ1bGxldGluX2lkIjoiMjAyMDA5MTQuMjcwNjEyMjEiLCJ1cmwiOiJodHRwczovL3d3dy5mZGEuZ292L21lZGljYWwtZGV2aWNlcy93b3Jrc2hvcHMtY29uZmVyZW5jZXMtbWVkaWNhbC1kZXZpY2VzL3dlYmluYXItcmVjb2duaXRpb24tYW5kLXdpdGhkcmF3YWwtdm9sdW50YXJ5LWNvbnNlbnN1cy1zdGFuZGFyZHMtZmluYWwtZ3VpZGFuY2UtMTAxNTIwMjAtMTAxNTIwMjA%5FdXRtX21lZGl1bT1lbWFpbCZ1dG1fc291cmNlPWdvdmRlbGl2ZXJ5In0.MYEBe-5NprvT6SXfXruipXGxucrpXJn9POlXpuT8U2U/s/1255931999/br/84846532637-l?ref=fdaweb.com) for industry and others interested in learning more about the guidance.