Internal FDA Menaflex Investigation Finds Serious Process Deviations

Article preview reprinted from "The Gray Sheet" - September 28, 2009

An internal evaluation of FDA's handling of the controversial 510(k) clearance of a knee implant unearthed serious shortcomings in the integrity of the agency's review process, FDA said Sept. 24. Read more...

Internal FDA Menaflex Investigation Finds Serious Process Deviations

Article preview reprinted from "The Gray Sheet" - September 28, 2009 

An internal evaluation of FDA's handling of the controversial 510(k) clearance of a knee implant unearthed serious shortcomings in the integrity of the agency's review process, FDA said Sept. 24.

The agency released preliminary findings from its review of the decision-making behind the December 2008 clearance of ReGen Biologics' Menaflex meniscus collagen scaffold for knee repair.

The report identified "numerous" departures from standard FDA procedures, Principle Deputy Commissioner Joshua Sharfstein said during a Sept. 24 media briefing. Among the observations: officials' failures to sufficiently document the basis for decisions, inappropriate responses to external pressure on decision makers, the "exclusion of individuals, if not viewpoints" from parts of the scientific debate and over-reliance on advisory panel deliberations.

"The message here is that there were problems with the integrity of FDA's decision-making," and that those problems have solutions, Sharfstein said. "FDA is committed to the integrity of its decisions and we will take the steps necessary to protect that."

Report Requests Broader 510(k) Review

The report calls on FDA to review and perhaps revise its procedures for handling differences of opinion within the device center and to better document the decision-making process, among other recommendations.

It also charges the agency to conduct a broader review of the 510(k) program. The report identifies several aspects of the 510(k) process that "appear to have contributed to confusion and dissent" during the Menaflex review, FDA's report states.

- Jessica Bylander

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