Tag Archives:intended use

FDA Finalizes Guidance on the Evaluation of 510(k) Substantial Equivalence

On July 28,2014,FDA issued an important final guidance relating to the Agency's substantive review of 510(k) notifications,entitled "The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]."  This guidance applies to the 510(k) review process for both diagnostic and therapeutic devices and is applicable to 510(k) reviews undertaken by the Center for … Continue Reading
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