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After Win, FDA May Backtrack On More Device Approvals

Law360, New York (April 29, 2013, 9:30 PM EDT) -- Earlier this month, a federal judge backed the U.S. Food and Drug Administration's decision to revoke its marketing clearance for a knee implant more than two years after it had initially granted it, a ruling that attorneys worry may embolden the agency to make similar retractions on other medical devices.

U.S. District Judge Robert Wilkins granted the FDA summary judgment April 10 in a suit brought by ReGen Biologics Inc., after the agency decided to rescind its clearance of ReGen's Menaflex knee implant.

The FDA had cleared the implant for marketing in December 2008, but after the change in administrations, the...

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Attached Documents



Case Information

Case Title

Subscribers Only

Case Number

Subscribers Only


District Of Columbia

Nature of Suit

Other Statutory Actions


Subscribers Only

Date Filed

May 31, 2011

Law Firms

Government Agencies