21 C.F.R. § 4.2
The terms listed in this section have the following meanings for purposes of this subpart:
Biological product has the meaning set forth in § 3.2(d) of this chapter. A biological product also meets the definitions of either a drug or device as these terms are defined under this section.
Combination product has the meaning set forth in § 3.2(e) of this chapter.
Constituent part is a drug, device, or biological product that is part of a combination product.
Co-packaged combination product has the meaning set forth in § 3.2(e)(2) of this chapter.
Current good manufacturing practice operating system means the operating system within an establishment that is designed and implemented to address and meet the current good manufacturing practice requirements for a combination product.
Current good manufacturing practice requirements means the requirements set forth under § 4.3(a) through (e) .
Device has the meaning set forth in § 3.2(f) of this chapter. A device that is a constituent part of a combination product is considered a finished device within the meaning of the Quality Management System Regulation (QMSR).
Drug has the meaning set forth in § 3.2(g) of this chapter and includes medical gas as defined in section 575(2) of the Federal Food, Drug, and Cosmetic Act. Medical gas includes designated medical gases as defined in section 575(1) of the Federal Food, Drug, and Cosmetic Act and medical gases approved under section 505 of the Federal Food, Drug, and Cosmetic Act. A drug other than a medical gas that is a constituent part of a combination product is considered a drug product within the meaning of the drug current good manufacturing practice (CGMP) requirements. A drug that is a medical gas that is a constituent part of a combination product is considered a medical gas within the meaning of the medical gas CGMP requirements.
Drug CGMP requirements refers to the current good manufacturing practice regulations set forth in parts 210 and 211 of this chapter.
HCT/Ps refers to human cell, tissue, and cellular and tissue-based products, as defined in § 1271.3(d) of this chapter. An HCT/P that is not regulated solely under section 361 of the Public Health Service Act may be a constituent part of a combination product. Such an HCT/P is subject to part 1271 of this chapter and is also regulated as a drug, device, and/or biological product.
Manufacture includes, but is not limited to, designing, fabricating, assembling, filling, processing, testing, labeling, packaging, repackaging, holding, and storage.
Medical gas CGMP requirements refers to the current good manufacturing practice regulations set forth in part 213 of this chapter.
QMSR refers to the requirements under part 820 of this chapter.
Single-entity combination product has the meaning set forth in § 3.2(e)(1) of this chapter.
Type of constituent part refers to the category of the constituent part, which can be either a biological product, a device, or a drug, as these terms are defined under this section.
21 C.F.R. §4.2