FDA Updates Recognized Consensus Standards Database with List 56

The U.S. Food and Drug Administration (FDA) has updated its Recognized Consensus Standards database. This latest update, known as List 56, adds new standards and new versions of recognized standards, as well as revisions to some standards’ extent of recognition.

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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 FDA may issue recognition numbers and provide supplemental information in the Recognized Consensus 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 for List 56 will be published later in 2021, though manufacturers may now cite these new and revised standards in device submissions.

Questions?

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