FDA Updates Standards Recognition Database with List 57

Learn more about the newly added standards and new versions of recognized standards.

If your email program has trouble displaying this email, view as a webpage. FDA Updates Recognized Consensus Standards Database with List 57  The U.S. Food and Drug Administration (FDA) has updated its Recognized Consensus Standards database. This latest update, known as "List 57," adds new standards and new versions of recognized standards.  View the Database 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 57 will be published later in 2022, though manufacturers may now cite these new and revised standards in device submissions.   There are format changes to the listing of US Pharmocopeia-National Formulary (USP-NF) standards. Please note that USP-NF has recently changed its publication from a printed edition to an online platform. FDA-recognized USP-NF standards will now feature the unique portion of their Digital Object Identifiers (DOI) as designation numbers.  Questions? If you have questions, contact the Division of Industry and Consumer Education.

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