CFR section
21 CFR 820.30(c): Design controls
PART 820-QUALITY SYSTEM REGULATION · Subpart C-Design Controls
Key facts
| Citation | 21 CFR 820.30(c) |
|---|---|
| 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, Food/Cosmetics, Other_Regulations |
| Regulation text (excerpt) | (c) Design input. Each manufacturer shall establish and maintain procedures to ensure that the design requirements relating to a device are appropriate and address the intended use of the device, including the needs of the user and patient. The procedures shall include a mechanism for addressing incomplete, ambiguous, or conflicting requirements. The design input requirements shall be documented and shall be reviewed and approved by a designated individual(s). The approval, including the date… |
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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.