FDA’s Substantial Equivalence Guidance Describes FDA’s Process for Evaluating Substantial Equivalence and Updates to the 510(k) Decision Flowchart

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The U.S. Food and Drug Administration (FDA) has issued a final guidance document titled The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)] (July 28, 2014) (“SE Guidance”). The SE Guidance discusses FDA’s process for evaluating 510(k) submissions and determining whether a new device is substantially equivalent (SE) to its predicate device(s). More specifically, the SE Guidance attempts to provide clarity on the following:

• Appropriate use of predicate devices, including multiple predicates;

• When new indications for use may be considered a new intended use;

• When different technological characteristics raise different questions of safety and effectiveness;

• When performance data, particularly clinical data, may be necessary to support an SE determination; and

• Preparation of 510(k) Summaries

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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