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

What You Need to Know? 👇

What is the 510(k) Third Party Review Program and how does it differ from traditional FDA review?

The 510(k) Third Party Review Program allows FDA-recognized organizations to review certain low-to-moderate risk devices and make recommendations to FDA. Unlike traditional FDA review, submitters pay the third party organization directly with no FDA user fee required, and FDA has 30 days to make final decisions after receiving recommendations.

Which medical devices are eligible for third party 510(k) review?

Eligible devices must be Class I or II (not Class III), well-understood device types, not permanently implanted/life-sustaining without justification, and not require complex interdisciplinary expertise. Devices with safety signals, novel technologies, or requiring multifaceted clinical data review are typically ineligible for third party review.

What are the key qualification requirements for becoming a recognized 3P510k Review Organization?

Organizations must be independent from device manufacturers, legally constituted entities not engaged in device design/manufacture, demonstrate qualified personnel meeting IMDRF standards, establish conflict of interest policies, maintain confidentiality procedures, and commit to accurate reporting and complaint resolution processes.

How does Third Party Emergency Use Authorization (EUA) review work during emergencies?

During declared emergencies under section 564, FDA may contract with qualified organizations to review EUA requests. Unlike 510(k) review, EUA submitters typically send requests to FDA first, who may forward them to contracted third party reviewers for recommendations on effectiveness and authorization conditions.

What documentation must Third Party Review Organizations provide to FDA with their recommendations?

Organizations must submit the complete original submission, a comprehensive review memorandum documenting their analysis and reasoning, a signed cover letter with their recommendation, certification statements, and documentation of any deficiencies identified and resolved during the review process.

How often must 3P510k Review Organizations renew their FDA recognition?

Recognition expires every three years and organizations must apply for rerecognition at least 60 days before expiration. FDA considers past performance, audit results, and continued compliance with qualification requirements. Organizations may also request earlier rerecognition or scope modifications as needed.

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What You Need to Do 👇

Recommended Actions

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

• 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

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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

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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 ID: cd857813ebe41cf80c11557a88da55fe