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Third Party Review Program for Medical Device 510k and Emergency Use Authorization Reviews

This guidance outlines FDA's expectations for the 510(k) Third Party (3P510k) Review Program and Third Party Emergency Use Authorization (EUA) Review. It covers: - The factors used to determine device eligibility for third-party review - The process for recognition and rerecognition of third-party review organizations - Requirements for conducting reviews and submitting recommendations to FDA - Expectations for preventing conflicts of interest and maintaining impartiality - Requirements for personnel qualifications and recordkeeping

  1. Establish and document policies and procedures to prevent conflicts of interest
  2. Implement a quality management system aligned with IMDRF requirements
  3. Ensure personnel meet qualification requirements and maintain documentation of their competencies
  4. Set up recordkeeping systems for:
    • Review documentation
    • Personnel qualifications
    • Complaints handling
    • Confidential information management
  5. Establish procedures for Early Interaction with FDA before reviewing new device types
  6. Implement eSTAR for 510(k) submissions
  7. Create templates for thorough review documentation
  8. Set up monitoring systems for postmarket safety signals
  9. Develop procedures for handling confidential information
  10. Create a training program to ensure personnel maintain required competencies

Key Considerations

Software

  • Software documentation level (basic or enhanced) should be clarified through Early Interaction with FDA
  • Organizations should be capable of interfacing with FDA’s electronic data systems and websites

Safety

  • Organizations must report any complaints that could indicate safety or effectiveness issues
  • Organizations must monitor postmarket databases including recalls, market withdrawals, and safety reports
  • Safety signals must be reported to FDA for further guidance

Other considerations

  • IEC/IEC 19510: Information technology – Object Management Group Business Process Model and Notation (2013)
  • IMDRF GRRP WG N40 FINAL:2017: Competence, Training, and Conduct Requirements for Regulatory Reviewers
  • IMDRF GRRP WG N59 Final:2020: Requirements for Regulatory Authority Recognition of Conformity Assessment Bodies Conducting Medical Device Regulatory Reviews
  • IMDRF GRRP WG N66: Assessment and Decision Process for the Recognition of a Conformity Assessment Body Conducting Medical Device Regulatory Reviews

Original guidance

  • Third Party Review Program for Medical Device 510k and Emergency Use Authorization Reviews
  • HTML / PDF
  • Issue date: 2024-11-21
  • Last changed date: 2024-11-20
  • Status: FINAL
  • Official FDA topics: Medical Devices, 510(k), Administrative / Procedural, Premarket
  • ReguVirta summary file ID: cd857813ebe41cf80c11557a88da55fe
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