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The U.S. Food and Drug Administration (FDA) has updated its Recognized Consensus Standards database. This latest update, known as "List 58," includes new standards and new versions of recognized standards, as well as revisions to some standards’ extent of recognition.
Facts About This Update
- According to the FDA’s 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.
- The next Federal Register notice with modifications to the listing of recognized consensus standards for List 58 will be published later in 2022, though manufacturers may now cite these new and revised standards in device submissions.
- The updated Recognized Consensus Standards Database includes one new standard and new versions for two existing standards included in the voluntary pilot program for the Accreditation Scheme for Conformity Assessment (ASCA). Check the database and the relevant Supplementary Information Sheets for more information.
Questions?
If you have questions, contact the Division of Industry and Consumer Education.
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