In the June 15, 2016, Federal Register, and June 27, 2016, Federal Register, FDA published modifications to the list of standards FDA recognizes for use in premarket reviews. The publications, titled "Modifications to the List of Recognized Standards, Recognition List Number: 042," and "Modifications to the List of Recognized Standards, Recognition List Number: 043," respectively, will assist manufacturers that elect to declare conformity with consensus standards to meet certain requirements for medical devices. FDA will incorporate these modifications in the list of FDA Recognized Consensus Standards in the Agency's searchable database. Modifications were effective June 15 and 27, 2016, respectively.
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