CFR section
21 CFR 820.30(f): Design controls
PART 820-QUALITY SYSTEM REGULATION · Subpart C-Design Controls
Key facts
| Citation | 21 CFR 820.30(f) |
|---|---|
| Section | Design controls |
| Part | PART 820-QUALITY SYSTEM REGULATION |
| Subpart | Subpart C-Design Controls |
| Subchapter | 21 CFR H Medical Devices |
| Product types cited | Biologics, Devices, Drugs, Food/Cosmetics, Other_Regulations |
| Regulation text (excerpt) | (f) Design verification. Each manufacturer shall establish and maintain procedures for verifying the device design. Design verification shall confirm that the design output meets the design input requirements. The results of the design verification, including identification of the design, method(s), the date, and the individual(s) performing the verification, shall be documented in the DHF. |
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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.