CFR 21-820.30 - Design Controls

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