No Changes Imminent for the 510(k) Process
BY LAUREN UZDIENSKI, DECEMBER 14, 2009
According to an editorial published in the Minneapolis Star Tribune, Dr. Jeffrey Shuren, acting director of the CDRH, has confirmed that no sweeping changes are imminent for the 510(k) process. The rigor of the 510(k) pathway has been a subject of discussion for several years, with concerns punctuated by the clearance of ReGen Biologics' Menaflex.
For the moment, the 510(k) process will remain as-is while the agency shifts management and awaits the results of several ongoing studies. Earlier this year the FDA conducted a review of the process by which Menaflex was cleared, concluding that there were several "deviations" from accepted practice; this led to the start of a second review to determine whether the product would stay on the market, results from which are still pending. Additionally, with the new administration, Dr. Daniel Schultz left his post as director of the CDRH. Further actions from the FDA to assess the 510(k) pathway include an internal working group as well as an IOM review, though results from that study are not expected to be public until 2011.
The article argues that these incremental changes and ongoing reviews are beneficial to the device industry and indicate an improvement from the "vague, nontransparent" practices of the FDA's former administration. This view suggests that the industry will gain from a more predictable FDA and that moderate changes are an appropriate means of refining the regulatory process. The industry has voiced some objection to arguments that the 510(k) should be entirely revamped, advocating for the validity of the 510(k) process and against a more burdensome pathway, which could lead to extended time-to-market and additional strain on young companies.
