01/18/2013 05:45:20 PM EST
FDA Wants Premarket Approval For Metal-On-Metal Hips In Wake Of Early Failure
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LexisNexis® Mealey's™ Daily Legal News
ROCKVILLE, Md. - The Food and Drug Administration on Jan. 18 published a proposed rule that would require manufacturers of metal-on-metal hips to prove their devices are safe and effective before they are approved ("Effective Date of Requirement for Premarket Approval for Two Class III Preamandments Devices," Fed. Reg., Vol. 78, No. 13, Friday, January 18, 2013/Proposed Rules).
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