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FDA Acknowledges Mistakes in Knee-Device Approval
Date:9/24/2009

Agency says it will review procedure for endorsing medical devices

THURSDAY, Sept. 24 (HealthDay News) -- The U.S. Food and Drug Administration violated procedures last year when it approved a knee repair device even though its own scientists recommended against approval, agency officials said Thursday.

The device, called Menaflex, is made by New Jersey-based ReGen Biologics and is used to help surgically repair knee damage -- specifically, damage to the meniscus. But, a report released by the agency Thursday found that some FDA scientists had recommended against approval.

"There were numerous departures from processes, procedures and practices, and there were problems with the review process for the device," Dr. Joshua Sharfstein, the FDA's principal deputy commissioner, said during an afternoon teleconference.

In addition, the FDA report noted that four New Jersey Democratic lawmakers -- Senators Robert Menendez and Frank Lautenberg and Representatives Frank Pallone Jr. and Steven R. Rothman -- made inquiries to agency officials about the device's approval status.

"Members of the delegation apparently had conversations with the [FDA] commissioner and at least one conversation with the [former] principal deputy commissioner," the report said.

Going forward, the FDA plans to review the process by which such medical devices are approved, Sharfstein said. "It will also include a reevaluation of the clearance of this device," he said.

However, there are no plans to remove the Menaflex device from the market, officials said.

"This device has been approved by the FDA, and we have no basis to question the safety of this device so it will remain on the market," Dr. Jeffrey Shuren, acting director of the FDA's Center for Devices and Radiological Health, said during the teleconference.

"What we have concluded is that the integrity of our process for reaching a decision was c
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