CFR section
21 CFR 820.250(a): Statistical techniques
PART 820-QUALITY SYSTEM REGULATION · Subpart O-Statistical Techniques
Key facts
| Citation | 21 CFR 820.250(a) |
|---|---|
| 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, General, Other_Regulations |
| Regulation text (excerpt) | (a) Where appropriate, each manufacturer shall establish and maintain procedures for identifying valid statistical techniques required for establishing, controlling, and verifying the acceptability of process capability and product characteristics. |
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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.