Entries in Center for Devices and Radiological Health (1)


FDA To Rescind Approval of Knee Implant Device

Photo Courtesy - Getty Images(WASHINGTON) -- The U.S. Food and Drug Administration said it will seek to revoke clearance for a collagen-based knee implant product called Menaflex after meeting with its manufacturer, according to MedPage Today

Although the FDA's Center for Devices and Radiological Health originally cleared the product in December 2008, the agency now says it should not have approved Menaflex under the 510(k) process.  The FDA has concluded that the 510(k) process was inappropriate for the product because it "is intended to be used for different purposes and is technologically dissimilar from devices already on the market."

ReGen Biologics, the product's manuafacturer said the product is meant "to provide a scaffold for new meniscal tissue to grow," MedPage reports.

However the FDA said that other approved products on the market merely provided replacement or support for damaged tissue to grow which is different from Menaflex's intended use.

The FDA did indicate that it would request a meeting with ReGen officials to discuss the necessary data for providing a reasonable assurance of safety and effectiveness and more appropriate marketing channels for the device before beginning the revocation process.

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