CFR section
21 CFR 820.86: Acceptance status
PART 820-QUALITY SYSTEM REGULATION · Subpart H-Acceptance Activities
Key facts
| Citation | 21 CFR 820.86 |
|---|---|
| Section | Acceptance status |
| Part | PART 820-QUALITY SYSTEM REGULATION |
| Subpart | Subpart H-Acceptance Activities |
| Subchapter | 21 CFR H Medical Devices |
| Product types cited | Biologics, Devices, Drugs |
| Regulation text (excerpt) | Each manufacturer shall identify by suitable means the acceptance status of product, to indicate the conformance or nonconformance of product with acceptance criteria. The identification of acceptance status shall be maintained throughout manufacturing, packaging, labeling, installation, and servicing of the product to ensure that only product which has passed the required acceptance activities is distributed, used, or installed. |
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About CFR sections cited by the FDA
Title 21 of the Code of Federal Regulations contains the FDA's regulations, including current good manufacturing practice and quality system requirements that inspections cite.