CFR section
21 CFR 820.30(d): Design controls
PART 820-QUALITY SYSTEM REGULATION · Subpart C-Design Controls
Key facts
| Citation | 21 CFR 820.30(d) |
|---|---|
| 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) | (d) Design output. Each manufacturer shall establish and maintain procedures for defining and documenting design output in terms that allow an adequate evaluation of conformance to design input requirements. Design output procedures shall contain or make reference to acceptance criteria and shall ensure that those design outputs that are essential for the proper functioning of the device are identified. Design output shall be documented, reviewed, and approved before release. The approval… |
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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.