United States:
FDA Modifies Recognized Consensus Standards For Medical Devices
19 February 2015
Jones Day
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In the January 27, 2015, Federal Register,
FDA published modifications it is making to the list of standards
FDA recognizes for use in premarket reviews. This publication will
assist manufacturers that elect to 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.
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