United States v. Endotec, Inc.
Court of Appeals for the Eleventh Circuit
1Opinion of the Court
WILSON, Circuit Judge:
Pursuant to the Medical Device Amendments (“MDA”), 21 U.S.C. § 360c, et seq., to the Food, Drug and Cosmetic Act (“FDCA”), 21 U.S.C. § 301, et seq., the Food & Drug Administration (“FDA”) regulates the introduction of medical devices into interstate commerce by requiring that a device meets certain rigorous standards. The United States of America (“Government”) filed a civil action seeking a permanent injunction against Endotec, Inc. and its two owners, Michael Pappas and Frederick F. Buechel 1 (collectively, “Appellees”), alleging that they (1) manufactured and…
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