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 (d).
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 QS regulation.
Complying with FDA’s Medical Device 21 CFR 820 Quality System Regulation. Design Control for Medical Devices: Meeting FDA’s 21 CFR 820.30 Rules for Quality Design and Manufacturing. The CAPA Clinic: Effective CAPA Systems, Failure Investigations & Complaint Management. Quality Risk Management for FDA/ICH Q9 Compliance. Requirements for devices in part 820 (21 CFR part 820) were first authorized by section 520(f) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360j(f)), which was among the authorities added to the act by the Medical Device Amendments of 1976 (Pub. Under section 520(f) of the act, FDA issued a final rule in the.
Drug has the meaning set forth in § 3.2(g) of this chapter. A drug that is a constituent part of a combination product is considered a drug product within the meaning of the drug CGMPs.
Drug CGMPs 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 solely regulated 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.
QS regulation refers to the quality system regulation in 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.
Title 21 Cfr Part 820 Pdf
