Recognition and Withdrawal of Voluntary Consensus Standards | FDA

Recognition and Withdrawal of Voluntary Consensus Standards | FDA

FDA Issues Final Guidance on Recognition and Withdrawal of Voluntary Consensus Standards

Today, the U.S. Food and Drug Administration (FDA) issued the final guidance: Recognition and Withdrawal of Voluntary Consensus Standards.

Read the Guidance

Facts about the final guidance

This final guidance explains the updated procedures the FDA intends to follow when the FDA receives requests for recognition of consensus standards and withdraws recognition of a consensus standard. In summary, the 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 with pending recognitions. As soon as FDA makes a determination to recognize a standard and it appears in the recognition database, manufacturers may cite them in premarket submissions; manufacturers will no longer have to wait for the publication of a Federal Register notice.

Upcoming webinar on this guidance:

• On Thursday, October 15, the FDA will host a webinar for industry and others interested in learning more about the guidance.

Questions?

If you have questions about this final guidance, contact CDRHStandardsStaff@fda.hhs.gov.