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United States v. Bowen

172 F.3d 682 (1999)

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United States v. Bowen

United States Court of Appeals for the Ninth Circuit
172 F.3d 682 (1999)

MP

Facts

The Food and Drug Administration (FDA) brought an action against Bowen, the manufacturer of instruments that are used to sterilize dental handpieces—SteriSafe Handpiece Sterilizer and SteriDot High Purity Water Ampule. The FDA alleged that the instruments were adulterated and that the SteriDot was misbranded in violation of the Federal Food, Drug, and Cosmetic Act (FDCA) and sought to enjoin Bowen from engaging these instruments in interstate commerce. The district court ruled for the FDA, and Bowen appealed and argued that neither instrument was a device under 21 U.S.C. § 321(h) of the FDCA.

Rule of Law

Issue

Holding and Reasoning (Graber, J.)

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