CFR section
21 CFR 820.170(a): Installation
PART 820-QUALITY SYSTEM REGULATION · Subpart L-Handling, Storage, Distribution, and Installation
Key facts
| Citation | 21 CFR 820.170(a) |
|---|---|
| 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, Drugs |
| Regulation text (excerpt) | (a) Each manufacturer of a device requiring installation shall establish and maintain adequate installation and inspection instructions, and where appropriate test procedures. Instructions and procedures shall include directions for ensuring proper installation so that the device will perform as intended after installation. The manufacturer shall distribute the instructions and procedures with the device or otherwise make them available to the person(s) installing the device. |
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.