FDA Updates Recognized Consensus Standards Database

The U.S. Food and Drug Administration (FDA) updated its Recognized Consensus Standards database. New or revised recognized standards were added and standards that are no longer recognized were withdrawn. Other updates include revisions to some standards’ extent of recognition and transition periods.

View the Updated Database

According to the FDA guidance, Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices, the FDA may determine which new or revised standards are appropriate for meeting requirements for medical devices under the Federal Food, Drug, and Cosmetic Act, and may issue recognition numbers and provide supplemental information in the standards database in advance of a Federal Register Notice. These standards may be used to support declarations of conformity in submissions. The next Federal Register Notice with modifications to the list of recognized consensus standards will be published later this year.

Questions

If you have questions about this updated database, contact the Division of Industry and Consumer Education.