21 CFR § 1.71 - Definitions.
For purposes of subpart D:
Automated Commercial Environment or ACE means the automated and electronic system for processing commercial importations that is operated by U.S. Customs and Border Protection in accordance with the National Customs Automation Program established in Subtitle B of Title VI - Customs Modernization, in the North American Free Trade Agreement Implementation Act (Pub. L. 103-182, 107 Stat. 2057, 2170, December 8, 1993) (Customs Modernization Act), or any other CBP-authorized EDI system.
CBP or U.S. Customs and Border Protection means the Federal Agency that is primarily responsible for maintaining the integrity of the borders and ports of entry of the United States.
FDA or Agency means the U.S. Food and Drug Administration.
Food contact substance means any substance, as defined in section 409(h)(6) of the Federal Food, Drug, and Cosmetic Act, that is intended for use as a component of materials used in manufacturing, packing, packaging, transporting, or holding food if such use is not intended to have any technical effect in such food.
HCT/Ps means human cells, tissues, or cellular or tissue-based products, as defined in § 1271.3(d) of this chapter.
Low-acid canned food means a thermally processed low-acid food (as defined in § 113.3(n) of this chapter) in a hermetically sealed container (as defined in § 113.3(j) of this chapter), and subject to the requirements in parts 108 and 113 of this chapter.
Medical device means a device as defined in section 201(h) of the Federal Food, Drug, and Cosmetic Act, that is intended for use in humans.
Radiation-emitting electronic product means an electronic product as defined in section 531 of the Federal Food, Drug, and Cosmetic Act.