CFR section
21 CFR 820.170(b): Installation
PART 820-QUALITY SYSTEM REGULATION · Subpart L-Handling, Storage, Distribution, and Installation
Key facts
| Citation | 21 CFR 820.170(b) |
|---|---|
| Section | Installation |
| Part | PART 820-QUALITY SYSTEM REGULATION |
| Subpart | Subpart L-Handling, Storage, Distribution, and Installation |
| Subchapter | 21 CFR H Medical Devices |
| Product types cited | Devices |
| Regulation text (excerpt) | (b) The person installing the device shall ensure that the installation, inspection, and any required testing are performed in accordance with the manufacturer's instructions and procedures and shall document the inspection and any test results to demonstrate proper installation. |
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.