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Expert Analysis

Assessing FDA Powers After A Failed 510(k) Rescinding

Law360, New York (October 15, 2014, 10:36 AM EDT) -- The D.C. Circuit recently held that the U.S. Food and Drug Administration lacks the authority to rescind a 510(k) clearance. In Ivy Sports Medicine LLC v. Burwell, Case No. 13-5139 (Sept. 26, 2014 D.C. Circ.), the D.C. Circuit reversed a contrary decision by a district court and ordered the lower court to vacate the FDA's decision and remand to the agency for further proceedings....

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