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 On Dec. 27, FDA issued a hotly anticipated draft guidance to replace the aging documents that have long defined the pathway by which most devices reach the U.S. market.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 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 [Editor’s note: Look for more coverage of this draft guidance in future issues of “The Gray Sheet.”]