US Federal Register - FDA Notices · August 24, 2026

FDA Recognized Consensus Standards: Modifications to Recognition List Number 066

Original title: Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 066

FDA announces updates to its list of recognized consensus standards for medical device premarket review and conformity declarations.

Low obligation Framework Medical Devices & IVD United States Medical devicesCE marking

The Food and Drug Administration (FDA or the Agency) is announcing a publication containing modifications the Agency is making to the list of standards FDA recognizes for use in premarket reviews (FDA Recognized Consensus Standards). This publication, entitled "Modifications to the List of Recognized Standards, Recognition List Number: 066" (Recognition List Number: 066), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices.

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