August 2010
The Food and Drug Administration’s (FDA’s) premarket notification (510(k)) process for the review of medical devices was established in 1976 and provides a more abbreviated mechanism of medical device premarket clearance than FDA’s Premarket Approval (PMA) process. As indicated by FDA, the 510(k) program, as it currently exists, aims to support FDA’s public health mission by meeting two important goals: making safe and effective medical devices available to consumers, and fostering innovation in the medical device industry. But in recent years, concerns have been raised within and outside of FDA about whether the current 510(k) program optimally achieves these goals.
In response, the FDA announced July 30th the availability for public comment of a two-volume set of documents entitled “Center for Devices and Radiological Health Preliminary Internal Evaluations,” which is comprised of the preliminary reports of two internal committees: The 510(k) Working Group and the Task Force on the Utilization of Science in Regulatory Decision Making. Volume I is entitled “510(k) Working Group Preliminary Report and Recommendations.” Volume II is entitled “Task Force on the Utilization of Science in Regulatory Decision Making Preliminary Report and Recommendations.”
Although some in industry have rushed to conclude that the FDA recommendations represent official changes to the 510(k) process, it is noteworthy to mention that the recommendations contained in the FDA reports are preliminary, and FDA has not made any final decisions on specific changes to pursue. The program hasn’t yet been officially revamped, and no final rulemaking has taken place in the Federal Register.
Industry has been invited by FDA to comment, and to propose other recommendations and/or alternatives. But there is a relatively short window of opportunity in which to do so: only until October 4. Instructions for submitting comments can be seen in the corresponding Federal Register notice.