Quality System Information Requirements for Premarket Submissions
This guidance is intended for manufacturers submitting Premarket Approval Applications (PMA), PMA Supplements, Product Development Protocols (PDP), Humanitarian Device Exemptions (HDE), and Modular Review Submissions. It provides guidance on the Quality System information required in these premarket submissions.
Recommended Actions
- Prepare comprehensive design control documentation including:
- Design and development plan
- Design input/output procedures
- Design review procedures
- Design verification/validation procedures
- Design transfer procedures
- Design change control procedures
- Develop manufacturing documentation including:
- Production flow diagram
- Process validation master plan
- Quality system procedures
- Environmental control procedures
- Equipment calibration procedures
- Establish quality system procedures for:
- Purchasing controls
- Acceptance activities
- Nonconforming product handling
- CAPA system
- Complaint handling
- MDR reporting
- Ensure risk management activities are integrated throughout the design process and documented
- Validate all manufacturing processes that cannot be fully verified by subsequent inspection and test
- Prepare facility information including:
- Facility identification details
- Contact information
- Inspection readiness date
- Format submission in organized volumes with proper identification of facilities and numbered pages
Key Considerations
Human Factors
- Human factors should be considered as part of design inputs
- Should be addressed in design validation to ensure device meets user needs
Software
- Software validation must be completed if device is automated with computer software
- System integration testing should be included
- Software used in production or quality system must be validated
Labelling
- Labeling and packaging requirements should be considered as design inputs
- Should be addressed in design outputs
Biocompatibility
- Biocompatibility should be considered as part of design inputs
Safety
- Safety requirements must be considered as design inputs
- Risk analysis must be completed by conclusion of design validation
- Risk management activities should occur throughout design process
- Risk analysis and management should be documented and updated
Other considerations
- Design Controls:
- Design and development planning required
- Design input/output procedures needed
- Design review procedures required
- Design verification/validation procedures needed
- Design transfer and change control procedures required
- Manufacturing Controls:
- Production flow diagram required
- Process validation procedures needed for processes that cannot be fully verified
- Quality system procedures required
- Purchasing controls procedures needed
- Acceptance activities procedures required
- Nonconforming product procedures needed
- CAPA procedures required
- Complaint handling procedures needed
Relevant Guidances
- Design Controls for Medical Device Manufacturers
- Content of Premarket Submissions for Device Software Functions
- Applying Human Factors Engineering and Usability Engineering to Medical Devices
- Use of ISO 10993-1 for Biological Evaluation and Testing of Medical Devices
Related references and norms
- 21 CFR 820: Quality System Regulation
Original guidance
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