Recognized Consensus Standards

Recognized Consensus Standards

Today, 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 deleted. 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 under the Food, Drug, and Cosmetic Act for medical devices, and may issue recognition numbers and provide supplemental information in the standards database in advance of a Federal Register Notice. The next Federal Register Notice with modifications to the list of recognized consensus standards will be published later this summer.

View the Updated Database Questions? If you have questions about this updated database, contact the Division of Industry and Consumer Education.