CFR section
21 CFR 820.130: Device packaging
PART 820-QUALITY SYSTEM REGULATION · Subpart K-Labeling and Packaging Control
Key facts
| Citation | 21 CFR 820.130 |
|---|---|
| Section | Device packaging |
| Part | PART 820-QUALITY SYSTEM REGULATION |
| Subpart | Subpart K-Labeling and Packaging Control |
| Subchapter | 21 CFR H Medical Devices |
| Product types cited | Devices |
| Regulation text (excerpt) | Each manufacturer shall ensure that device packaging and shipping containers are designed and constructed to protect the device from alteration or damage during the customary conditions of processing, storage, handling, and distribution. |
At a glance
- 10–99 Inspections citing this section
- 1–9 Warning letters citing this section
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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.