CFR section
21 CFR 820.30(j): Design controls
PART 820-QUALITY SYSTEM REGULATION · Subpart C-Design Controls
Key facts
| Citation | 21 CFR 820.30(j) |
|---|---|
| Section | Design controls |
| Part | PART 820-QUALITY SYSTEM REGULATION |
| Subpart | Subpart C-Design Controls |
| Subchapter | 21 CFR H Medical Devices |
| Product types cited | Devices, Drugs, General, Other_Regulations |
| Regulation text (excerpt) | (j) Design history file. Each manufacturer shall establish and maintain a DHF for each type of device. The DHF shall contain or reference the records necessary to demonstrate that the design was developed in accordance with the approved design plan and the requirements of this part. |
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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.