CFR section
21 CFR 820.160(a): Distribution
PART 820-QUALITY SYSTEM REGULATION · Subpart L-Handling, Storage, Distribution, and Installation
Key facts
| Citation | 21 CFR 820.160(a) |
|---|---|
| Section | Distribution |
| Part | PART 820-QUALITY SYSTEM REGULATION |
| Subpart | Subpart L-Handling, Storage, Distribution, and Installation |
| Subchapter | 21 CFR H Medical Devices |
| Product types cited | Devices, Drugs, Food/Cosmetics, General |
| Regulation text (excerpt) | (a) Each manufacturer shall establish and maintain procedures for control and distribution of finished devices to ensure that only those devices approved for release are distributed and that purchase orders are reviewed to ensure that ambiguities and errors are resolved before devices are released for distribution. Where a device's fitness for use or quality deteriorates over time, the procedures shall ensure that expired devices or devices deteriorated beyond acceptable fitness for use are not… |
At a glance
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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.