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.
What You Need to Know? 👇
What quality system information is required for PMA submissions?
PMA submissions must include design control information (planning, inputs, outputs, reviews, verification, validation, transfer, changes, and history files) and manufacturing information (quality procedures, production flow, purchasing controls, process validation, acceptance activities, nonconforming product handling, CAPA procedures, complaint handling, and servicing procedures where applicable).
When should process validation be completed for medical device manufacturing?
Process validation plans and procedures must be in place at submission time, but actual validation completion is required before the preapproval inspection and prior to distribution of any finished devices. Validation is mandatory when process results cannot be fully verified by subsequent inspection and testing.
How should design control information be submitted in modular reviews?
FDA recommends submitting design control and manufacturing information in separate modules from other information for simplicity. General information should be included with both submissions to provide reviewers ready access to basic information and avoid delays in referencing across modules.
What documentation is needed for design changes under quality systems?
Design change procedures must describe when and how change control is used, ensure changes are validated or verified before implementation, explain when verification can be used instead of validation, and describe how manufacturing process changes will be managed within the design control system.
How should multiple manufacturing facilities be addressed in QS submissions?
When multiple facilities are involved in device design, assembly, or processing, applicable quality system information for each facility should be submitted in separate volumes that clearly identify the specific facility to which the information applies, including full facility identification and relationship details.
What is the relationship between CAPA systems and risk management programs?
CAPA procedures must explain how the corrective and preventive action system is tied to the risk management program, address both nonconforming practices and products, analyze multiple quality system data inputs, and ensure design changes made under CAPA interact properly with design change controls.
What You Need to Do 👇
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