CFR section
21 CFR 820.80(d): Receiving, in-process, and finished device acceptance
PART 820-QUALITY SYSTEM REGULATION · Subpart H-Acceptance Activities
Key facts
| Citation | 21 CFR 820.80(d) |
|---|---|
| Section | Receiving, in-process, and finished device acceptance |
| Part | PART 820-QUALITY SYSTEM REGULATION |
| Subpart | Subpart H-Acceptance Activities |
| Subchapter | 21 CFR H Medical Devices |
| Product types cited | Biologics, Devices, Drugs, Food/Cosmetics, General, Other_Regulations |
| Regulation text (excerpt) | (d) Final acceptance activities. Each manufacturer shall establish and maintain procedures for finished device acceptance to ensure that each production run, lot, or batch of finished devices meets acceptance criteria. Finished devices shall be held in quarantine or otherwise adequately controlled until released. Finished devices shall not be released for distribution until: (1) The activities required in the DMR are completed; (2) the associated data and documentation is reviewed; (3) the… |
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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.