CFR section
21 CFR 820.200(b): Servicing
PART 820-QUALITY SYSTEM REGULATION · Subpart N-Servicing
Key facts
| Citation | 21 CFR 820.200(b) |
|---|---|
| Section | Servicing |
| Part | PART 820-QUALITY SYSTEM REGULATION |
| Subpart | Subpart N-Servicing |
| Subchapter | 21 CFR H Medical Devices |
| Product types cited | Devices |
| Regulation text (excerpt) | (b) Each manufacturer shall analyze service reports with appropriate statistical methodology in accordance with § 820.100. |
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.