On July 28, 2014, FDA issued its final guidance on evaluating substantial equivalence in 510(k) submissions. The guidance, titled The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications¸ is FDA's first update to the 1986 "blue book" document, Guidance on the CDRH Premarket Notification Review Program, 510(k) Memorandum K86-3. FDA says it developed the guidance around current review practices and does not intend for it to implement significant policy changes. The guidance disallows split predicates, encourages the designation of a primary predicate when a 510(k) refers to more than one predicate device, and defines the terms "reference device," "intended use," and "indications for use." The guidance also uses illustrative examples to explain FDA policies for determining when new indications for use constitute a different intended use, as well as when differences in technological characteristics bring up safety and effectiveness issues. FDA will officially require performance data, encourage 510(k) summaries (rather than statements), and promote greater transparency in those summaries. The final guidance incorporates very few changes from the draft guidance issued in December 2011.
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