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In the July 9, 2014, Federal Register, FDA announced modifications
to the list of recognized standards the Agency uses in premarket
reviews (FDA Recognized Consensus Standards). The publication, Modifications to the List of Recognized Standards,
Recognition List Number: 036, will assist manufacturers that
declare conformity with consensus standards to meet certain
requirements for medical devices.
The content of this article is intended to provide a general
guide to the subject matter. Specialist advice should be sought
about your specific circumstances.
