Difference between revisions of "CFR 21-820.30 - Design Controls"
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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: | 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]] | ||
= Overview of Medical Device Design and its Control= | = Overview of Medical Device Design and its Control= | ||
| Line 24: | Line 25: | ||
=Terms= | =Terms= | ||
| − | * [[ | + | |
| − | * [[ | + | * [[CFR 21-820.20 - Management Control Flowchart]] |
| − | * [[ | + | * [[CFR 21-820.20 - Management Responsibility]] |
| − | * [[ | + | * [[CFR 21-820.20a - Quality System]] |
| − | * [[ | + | * [[CFR 21-820.20b - Organization]] |
| − | * [[ | + | * [[CFR 21-820.20c - Management review]] |
| − | * [[ | + | * [[CFR 21-820.20d - Quality Planning]] |
| − | * [[ | + | * [[CFR 21-820.20e - Quality System Procedures]] |
| − | * [[ | + | * [[CFR 21-820.25 - Personnel]] |
| − | * [[ | + | * [[CFR 21-820.25 - Personnel - General]] |
| − | * [[ | + | * [[CFR 21-820.25 - Personnel - Training]] |
| − | * [[ | + | * [[Device Master File]] |
| + | * [[Device Master Record]] | ||
[[Category:fda]] | [[Category:fda]] | ||
Latest revision as of 16:54, 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
Overview of Medical Device Design and its Control
Terms
- CFR 21-820.20 - Management Control Flowchart
- CFR 21-820.20 - Management Responsibility
- CFR 21-820.20a - Quality System
- CFR 21-820.20b - Organization
- CFR 21-820.20c - Management review
- CFR 21-820.20d - Quality Planning
- CFR 21-820.20e - Quality System Procedures
- CFR 21-820.25 - Personnel
- CFR 21-820.25 - Personnel - General
- CFR 21-820.25 - Personnel - Training
- Device Master File
- Device Master Record
