CFR section
21 CFR 820.250(b): Statistical techniques
PART 820-QUALITY SYSTEM REGULATION · Subpart O-Statistical Techniques
Key facts
| Citation | 21 CFR 820.250(b) |
|---|---|
| Section | Statistical techniques |
| Part | PART 820-QUALITY SYSTEM REGULATION |
| Subpart | Subpart O-Statistical Techniques |
| Subchapter | 21 CFR H Medical Devices |
| Product types cited | Devices, Drugs, Food/Cosmetics, Other_Regulations |
| Regulation text (excerpt) | (b) Sampling plans, when used, shall be written and based on a valid statistical rationale. Each manufacturer shall establish and maintain procedures to ensure that sampling methods are adequate for their intended use and to ensure that when changes occur the sampling plans are reviewed. These activities shall be documented. |
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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.