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.
- Title 21 - Food and Drugs. Chapter I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) Subchapter H - MEDICAL DEVICES. Part 820 - QUALITY SYSTEM REGULATION. Subpart C - Design Controls. Section 820.30 - Design controls.
- View Title 21 on govinfo.gov; View Title 21 Section 820.30 PDF; These links go to the official, published CFR, which is updated annually. As a result, it may not include the most recent changes applied to the CFR. You can learn more about the process here.
CFR - Code of Federal Regulations Title 21. Education Details: Apr 01, 2020 For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR). § 820.1 - Scope. § 820.3 - Definitions. § 820.5 - Quality system. § 820.20 - Management responsibility. § 820.22 - Quality audit. § 820.25 - Personnel. § 820.30 - Design controls. § 820.40 - Document. CFR - Code of Federal Regulations Title 21. Education Details: Apr 01, 2020 For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR). § 820.1 - Scope. § 820.3 - Definitions. § 820.5 - Quality system. § 820.20 - Management responsibility. § 820.22 - Quality audit. § 820.25 - Personnel. § 820.30 - Design controls. § 820.40 - Document. 21 CFR 820.200 - Servicing. FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED).
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.
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.
Title 21 Cfr Part 820 Pdf
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.
21 Cfr Part 820 Pdf
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.