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...
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Case Information

Case Title

REGEN BIOLOGICS, INC. v. SEBELIUS et al


Case Number

1:11-cv-01006

Court

District Of Columbia

Nature of Suit

Other Statutory Actions

Judge

Rudolph Contreras

Date Filed

May 31, 2011

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