The U.S. Food and Drug Administration (FDA) has issued two draft guidance documents that address voluntary consensus standards. As coordinator of the U.S. standardization system, the American National Standards Institute (ANSI) encourages stakeholders to submit comments to the FDA.
The FDA guidance documents are accessible below:
- Recognition and Withdrawal of Voluntary Consensus Standards: Draft Guidance
- Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices: Final Guidance
The FDA developed the Recognition and Withdrawal of Voluntary Consensus Standards: Draft Guidance to inform industry and FDA staff about the procedures the Center for Devices and Radiological Health (CDRH) follows. Visit the FDA's Standards and Conformity Assessment Program webpage for more information.
Appropriate Use of Voluntary Consensus Standards: Final Guidance describes the appropriate use and documentation of consensus standards for premarket submissions, and how the FDA intends to rely on consensus standards during the review process. The guidance provides further clarity and explanation about the regulatory framework, policies, and practices regarding the appropriate utilization of consensus standards for premarket submissions.
The FDA will host a webinar on October 25 from 1:00 p.m. to 2:00 p.m. EST for manufacturers and others interested in learning more about the Appropriate Use Final Guidance. (Dial: 800-475-0481, International Callers Dial: 1-517-308-9467; Conference Number: 8090070; Passcode: 2387655).
Draft guidance will be open for public comments and suggestions for 60 days at https://www.regulations.gov under Docket Number: FDA-2018-D-2936.