FDA Issues Two Guidances on Voluntary Consensus Standards

Today, the U.S. Food and Drug Administration (FDA) has posted two guidance documents: Recognition and Withdrawal of Voluntary Consensus Standards: Draft Guidance Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices : Final Guidance Once finalized, the Recognition and Withdrawal of Voluntary Consensus Standards guidance will explain the regulatory framework and policies of FDA’s Center for Devices and Radiological Health (CDRH) during the evaluation of a voluntary consensus standard for recognition and situations where CDRH may withdraw recognition of a standard. All requests for recognition of a voluntary consensus standard are managed by CDRH, including any requests for recognition of a standard that would apply primarily or solely to a device regulated by FDA’s Center for Biologics Evaluation and Research. The draft guidance will be open for public comments and suggestions for 60 days athttps://www.regulations.gov under Docket Number: FDA-2018-D-2936. The Appropriate Use of Voluntary Consensus Standards final guidance describes the appropriate use and documentation of consensus standards for premarket submissions and how FDA staff intends to rely on consensus standards during the review process. Appropriate use of voluntary consensus standards can reduce requests from FDA staff for additional information to address issue(s) the standard was intended to address.  This guidance provides further clarity and explanation about the regulatory framework, policies, and practices regarding the appropriate utilization of consensus standards for premarket submissions. WEBINAR: On Thursday, October 25th, the FDA will host a webinar for manufacturers and others interested in learning more about the Appropriate Use final guidance. FDA employees are welcome to participate in this webinar and may join in listen-only mode. No registration is required. Date: Thursday, October 25, 2018 Time: 1:00 – 2:00pm EST (To ensure you are connected, please dial-in 15 minutes prior to the start of the webinar) To hear the presentation and ask questions: Dial: 800-475-0481, International Callers Dial: 1-517-308-9467; Conference Number: 8090070; Passcode: 2387655 To view the slide presentation during the webinar: https://www.mymeetings.com/nc/join.php?i=PWXW8090070&p=2387655&t=c  Following the webinar, a transcript, audio recording, and slides will be available at:http://www.fda.gov/CDRHWebinar. The slide presentation will also be available at this site on the morning of the webinar. To ensure you are connected, please dial-in 15 minutes prior to the start of the webinar. Following the webinar, a transcript, recording and slides will be available at:http://www.fda.gov/CDRHWebinar. The slide presentation will also be available at this site on the morning of the webinar. To learn more about CDRH’s standards program, please visit the Standards and Conformity Assessment Program webpage. If you have any questions, please contact CDRH’s Division of Industry and Consumer Education (DICE) at DICE@fda.hhs.gov, or via phone at 1-800-638-2041, or 301-796-7100. Thank you. Center for Devices and Radiological Health Food and Drug Administration