United States: FDA Publishes Modification To Recognized Consensus Standards For Medical Devices

In the February 11, 2015, Federal Register, FDA issued a publication containing modifications to the list of standards FDA recognizes for use in premarket reviews ("FDA Recognized Consensus Standards"). Specifically, this publication adds a list of recognized standards relevant to safety considerations to mitigate the risks of misconnections with small-bore connectors intended for enteral applications. The publication, entitled "Modifications to the List of Recognized Standards, Recognition List Number: 039," will assist manufacturers that elect to declare conformity with consensus standards to meet certain requirements for medical devices.

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