CFR 21-820 - Quality System Regulations

These regulations implement FDA's responsibilities and authority over medical device manufacturers management, design, development, verficiation, manufacture, validation, distributoin, installation, support, quality assurance and records for each new or listed device.

This regulation is the major regulatory thrust of day-to-day FDA oversight of device manufacturers and the focus of this book. Most of the remaining chapers are specific to the Quality System Regulation. These regulations are also the agency's attempt to harmonize medical device regulation with international quality standards, specifically ISO 9000.

The Quality System Regulations are philosophically simple:

• Comply with the regulations
• Say what you do
• Do what you say
• Document that you have done what you say

The CFR regulations described with respect to Quality System Regulations are:

• CFR 21-007 - Enforcement Policy - Recalls
• CFR 21-011 - Electronic Records; Electronic Signatures
• CFR 21-1010 - Performance Standards for Electronics Products
• CFR 21-801 - Labeling
• CFR 21-803 - Medical Device Reporting
• CFR 21-806 - Medical Devices; reports of corrections and removals
• CFR 21-807 - Establishment Registration and Device Listing
• CFR 21-814 - Premarket Approval of Medical Devices
• CFR 21-820 - Quality System Regulations
• 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
• 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 21-821 - Medical Device Tracking Requirements
• CFR 21-840 - Document Controls
• CFR 21-860 - Medical Device Classification Procedures
• CFR 21-861 - Procedures for Performance Standards Development
• CFR 21-892 - Radiological Devices
• CFR 21-895 - Banned Devices
• Device Master File
• Device Master Record