CFR 21-820.20 - Management Responsibility

The CFR regulations described with respect to Management Responsibility 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

The FDA preannouncement call will request a copy of:

• the firm's quality policy system procedure
• The Quality Manual
• The Quality Plan

FDA Inspection

• The investigators will review the written Quality Policy and will assess it to ensure that it defines tthe firm's overall quality intention
• The investigators will determine whether the firms Management with executive responsibility ensures that the quality policy is understood at all levels of the organization.
• Investigators will determine whethere management reviews and quality audits are being conducted in correspondence with written procedures.
• They will evaluate the firms Quality Plan to determine if the firm's quality practices, resources and activities are relevant and specific to the regulated medical devices that are manufactured.

Each manufacturer must prepare and implement all activities the applicable requirements of the Quality System Regulation that are necceary to assure that the device, the design process, the manufacturing process and all related activities conform to approved specifications.

Management Representative

The FDA expects that a firm has a documented management representative that has review and approval responsibility for appropriate milestones in the quality system. Investigators will assess a firms:

• Organizational Chart
• Quality Manual
• Design Control Activities
• Complaint Procedures
• Medical Device reporting procedures
• Quality Audit Procedure and schedule
• Quality reaudits, audit reports and corrective and preventive actions.

The management representatives 'fingerprints' should be all over these activities.

The management control flow chart indicates which steps may be taken during FDA Inspection