Early Collaboration Meetings for Medical Device Development: Determination and Agreement Procedures

What You Need to Know? 👇

What are FDAMA Early Collaboration Meetings and who can request them?

FDAMA provides two types of early collaboration meetings: Determination Meetings for PMA/PDP applicants to establish required scientific evidence, and Agreement Meetings for Class III devices or implants (including 510(k) eligible devices) to agree on investigational plan parameters.

How long does it take to schedule and receive outcomes from FDAMA meetings?

Agreement Meetings must be held within 30 days of request receipt. For Determination Meetings, FDA contacts applicants within 30 days to schedule. Written determinations or agreements are provided within 30 days after the meeting occurs.

Are the outcomes from FDAMA Early Collaboration Meetings legally binding on FDA?

Yes, both meeting types produce binding commitments. FDA can only change determinations if contrary to public health, or change agreements when substantial scientific issues essential to safety/effectiveness are identified, requiring additional applicant consultation.

What documentation must be submitted when requesting an FDAMA meeting?

Requests require detailed device descriptions, proposed conditions of use, effectiveness evaluation plans, expected performance information, and for Agreement Meetings, detailed clinical protocols. Submissions should be approximately 10-20 pages and submitted in triplicate.

Can FDAMA meetings be conducted remotely or must they be in-person?

Meetings may be conducted face-to-face, by videoconference, or teleconference. They are typically scheduled for 1-2 hours and may include preliminary meetings to review submissions and identify key issues before formal meetings.

What happens if the device design or intended use changes after an FDAMA meeting?

If applicants significantly change the bases of the agreement or determination (intended use, product design, investigational plan, clinical protocol), the binding commitment is abrogated and FDA’s determination or agreement is no longer in effect.

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What You Need to Do 👇

Recommended Actions

1. Contact appropriate FDA branch for initial discussion before requesting formal meeting
2. Submit formal meeting request with required documentation:
   • Detailed device description
   • Proposed conditions of use
   • Evaluation plan
   • Available performance data
   • Clinical protocol (for Agreement Meetings)
3. Arrange preliminary meeting to:
   • Review submitted information
   • Identify key issues
   • Determine if additional information is needed
4. Ensure decision-makers attend formal meeting
5. Document meeting outcomes:
   • Draft minutes within 7 days
   • Exchange with FDA for review
   • Complete evaluation checklist
6. Monitor compliance with agreements and notify FDA of any significant changes that could void agreements
7. Consider using informal pre-IDE meetings before formal binding meetings when dealing with novel technologies

Key Considerations

Clinical testing

• FDA must determine if clinical studies are needed to establish effectiveness
• Must consider least burdensome way of evaluating device effectiveness
• Agreement on clinical protocol parameters including:
  • Sample size and statistical justification
  • Inclusion/exclusion criteria
  • Primary and secondary endpoints
  • Study success criteria
  • Study duration
  • Number of sites

Non-clinical testing

• Pre-clinical testing may be considered in lieu of clinical data
• Previously collected non-US data, literature, and registry data may be acceptable

Safety

• Risk analysis must be included in proposed clinical evaluation plan
• Data Monitoring Committee operations may need to be specified
• Special informed consent provisions may be required

Other considerations

• Detailed device description required including:
  • Engineering drawings
  • Device composition/materials
  • Mechanism of action
  • Specifications
  • Failure mode analysis
• Proposed conditions of use must be outlined
• Meetings should occur early in device development
• Agreements are binding unless substantial scientific issues arise
• Changes to device design or intended use may void agreements

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Relevant Guidances 🔗

• Least Burdensome Principles for Medical Device Regulation
• Types of Communication During Medical Device Submissions Review
• Q-Submission Program: Strategic Framework for FDA Interactions in Medical Device Development

Related references and norms 📂

• 21 CFR 812.25: Requirements for investigational plans

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Original guidance

• Early Collaboration Meetings for Medical Device Development: Determination and Agreement Procedures
• HTML / PDF
• Issue date: 2001-02-27
• Last changed date: 2023-08-10
• Status: FINAL
• Official FDA topics: Medical Devices, Investigational Device Exemption (IDE), Premarket
• ReguVirta ID: 0cb0494612efcde51a6af791cc3f6b62