Difference between revisions of "Test"
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| − | The | + | Read the official FDA guidance to design controls [[http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm070642.pdf|here]]. 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]] | ||
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| − | + | [[Category:fda]] | |
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Revision as of 16:57, 27 August 2020
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