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Read the official FDA guidance to design controls [[1]]. The CFR regulations described with respect to Design Controls are:
- CFR 21-820.30a - General
- CFR 21-820.30b - Design and development planning
- CFR 21-820.30c - Design Input
- CFR 21-820.30d - Design Output
- CFR 21-820.30e - Design Review
- CFR 21-820.30f - Design Verification
- CFR 21-820.30g - Design Validation
- CFR 21-820.30h - Design Transfer
- CFR 21-820.30i - Design Changes
- CFR 21-820.30j - Design History File
- CFR 21-820.40a - Document approval and distribution
- CFR 21-820.40b - Document Changes
- CFR 21-840 - Document Controls
