FDA: Menaflex Clearance Shows "Definite Threats" to the 510(k) Process
BY LAUREN UZDIENSKI, SEPTEMBER 24, 2009
Yesterday the FDA issued a preliminary report on the process by which ReGen Biologics obtained 510(k) market clearance for its Menaflex device, concerns that were first publicized by the Wall Street Journal earlier this year. The Journal initially reported that ReGen turned to several New Jersey lawmakers to pressure the FDA into issuing a favorable clearance decision after two prior failures and numerous challenges from scientists. The company was also alleged to have unfairly influenced their review panel, all scenarios that the FDA has now confirmed in their report in what they called a "deterioration" of their own regulatory process.
Deputy director of the FDA Joshua Sharfstein said the numerous deviations from standard procedure in the Menaflex case reflected "definite threats" to the 510(k) process, which is currently undergoing an internal review at the agency. Additionally, the FDA announced this week that the IOM will conduct a review of the integrity of the clearance process, with a report to be issued in 2011. The undertaking of these reviews is at least partially attributable to the ReGen case. There have also been staff changes since the ReGen news broke, with CDRH head Dan Schultz resigning from the agency last month. He was replaced by acting CDRH director Dr. Jeffrey Shuren, one of the people overseeing the ReGen review.
Sharfstein noted that the review was not concerned with the safety of the device, only with the process by which it was cleared. Menaflex will remain on the market pending further review, which the Wall Street Journal says could take several months.
Without speaking to the ReGen debacle, AdvaMed defended the 510(k) in a statement released Wednesday, calling it "a well-defined, science-driven method used by FDA as part of a comprehensive regulatory framework."
The FDA's report is available from the New York Times.
