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
Biological product means a biological product as defined in section 351(i)(1) of the
Cosmetic means a cosmetic as defined in section 201(i) of the Federal
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.
Drug means those articles meeting the definition of a drug in section 201(g)(1) of the Federal
FDA or Agency means the U.S.
Food means food as defined in section 201(f) of the Federal
Food contact substance means any substance, as defined in section 409(h)(6) of the Federal
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
Radiation-emitting electronic product means an electronic product as defined in section 531 of the Federal
Tobacco product means a tobacco product as defined in section 201(rr) of the Federal