FDA issues major new 510(k) guidance

Article preview from "The Gray Sheet"- January 3, 2012

Companies planning to submit a 510(k) anytime in the future have some reading to do. On Dec. 27, FDA issued a hotly anticipated draft guidance to replace the aging documents that have long defined the pathway by which most devices reach the U.S. market.

The document, titled “The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)],” includes a revised, somewhat simplified version of its 1986 510(k) decision-making flowchart to aid substantial equivalence decisions and a new version of the 1998 "New 510(k) Paradigm" flowchart that helps determine when condensed 510(k) submissions – either “special” or “abbreviated” – are appropriate.

The draft addresses many of the meaty topics that have sparked debate during the device center’s protracted 510(k) reform process, including when clinical data might be needed in a 510(k), how a device’s “indications for use” relate to potential changes in its “intended use,” how and how not to rely on multiple predicates, and how to determine if new technological characteristics raise new questions of safety and effectiveness. It also puts new emphasis on ensuring that “510(k) Summaries” submitted with the pre-market notification applications are accurate and up to date.

Comments are due April 27. CDRH says it will be offering a free online training program on the guidance. [Editor’s note: Look for more coverage of this draft guidance in future issues of “The Gray Sheet.”]