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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.

  1. 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
  2. Develop manufacturing documentation including:
    • Production flow diagram
    • Process validation master plan
    • Quality system procedures
    • Environmental control procedures
    • Equipment calibration procedures
  3. Establish quality system procedures for:
    • Purchasing controls
    • Acceptance activities
    • Nonconforming product handling
    • CAPA system
    • Complaint handling
    • MDR reporting
  4. Ensure risk management activities are integrated throughout the design process and documented
  5. Validate all manufacturing processes that cannot be fully verified by subsequent inspection and test
  6. Prepare facility information including:
    • Facility identification details
    • Contact information
    • Inspection readiness date
  7. 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

  • 21 CFR 820: Quality System Regulation

Original guidance

  • Quality System Information Requirements for Premarket Submissions
  • HTML / PDF
  • Issue date: 2003-02-03
  • Last changed date: 2020-03-19
  • Status: FINAL
  • Official FDA topics: Medical Devices, Premarket, Premarket Approval (PMA)
  • ReguVirta summary file ID: 1676ad7176d0e7ee90b78c481d3081d9
This post is licensed under CC BY 4.0 by the author.