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GENUS MEDICAL TECH. v. U.S. FOOD AND DRUG ADMIN.

No. 20-5026.

994 F.3d 631 (2021)

GENUS MEDICAL TECHNOLOGIES LLC, Appellee, v. UNITED STATES FOOD AND DRUG ADMINISTRATION, Appellant.

United States Court of Appeals, District of Columbia Circuit.

Decided April 16, 2021.

Attorney(s) appearing for the Case

Daniel Winik , Attorney, U.S. Department of Justice, argued the cause for appellant. With him on the briefs were Jeffrey Bossert Clark , Acting Assistant Attorney General, Scott R. McIntosh , Attorney, Robert P. Charrow , General Counsel, U.S. Department of Health and Human Services, AnnaMarie Kempic , Deputy Chief Counsel for Litigation.

Noam B. Fischman , Washington, DC, was on the brief for amicus curiae Bracco Diagnostics Inc. in support of appellant.

James A. Boiani , Washington, DC, was on the brief for amicus curiae Giskit B.V. in support of appellant.

Douglas B. Farquhar , Washington, DC, argued the cause and filed the brief for appellee.

Opinion concurring in the judgment filed by Circuit Judge Pillard.

The Federal Food, Drug, and Cosmetic Act (FDCA or Act), 21 U.S.C. §§ 301 et seq., sets forth separate and detailed regimes for the regulation of medical products classified, inter alia, as drugs or devices. The question before us is whether the U.S. Food and Drug Administration (FDA...

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