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


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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