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
Recommended Actions
- Establish and document policies and procedures to prevent conflicts of interest
- Implement a quality management system aligned with IMDRF requirements
- Ensure personnel meet qualification requirements and maintain documentation of their competencies
- Set up recordkeeping systems for:
- Review documentation
- Personnel qualifications
- Complaints handling
- Confidential information management
- Establish procedures for Early Interaction with FDA before reviewing new device types
- Implement eSTAR for 510(k) submissions
- Create templates for thorough review documentation
- Set up monitoring systems for postmarket safety signals
- Develop procedures for handling confidential information
- 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
- Organizations must be independent and free from conflicts of interest
- Personnel must have appropriate education, training, skills and experience
- Organizations must maintain confidentiality of information
- Organizations must keep records for at least 3 years
- Organizations must use eSTAR for 510(k) submissions
- Early Interaction with FDA is required before reviewing new device types
- Organizations must have quality management systems in place
- Organizations must document their review process thoroughly
Relevant Guidances
- Content of Premarket Submissions for Device Software Functions
- Electronic Submission Template And Resource (eSTAR) for 510k Submissions
- Quality System Information Requirements for Premarket Submissions
- Content and Decision-Making Process for 510k Submissions: Determining Substantial Equivalence
Related references and norms
- 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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