Early Collaboration Meetings for Medical Device Development: Determination and Agreement Procedures
This guidance outlines the procedures for two types of early collaboration meetings between FDA and medical device companies under FDAMA: 1. Determination Meetings: To determine the type of scientific evidence needed to demonstrate device effectiveness 2. Agreement Meetings: To reach agreement on key parameters of investigational plans for Class III devices and implants The meetings aim to provide clear direction early in device development and establish binding commitments between FDA and applicants regarding testing requirements.
Recommended Actions
- Contact appropriate FDA branch for initial discussion before requesting formal meeting
- Submit formal meeting request with required documentation:
- Detailed device description
- Proposed conditions of use
- Evaluation plan
- Available performance data
- Clinical protocol (for Agreement Meetings)
- Arrange preliminary meeting to:
- Review submitted information
- Identify key issues
- Determine if additional information is needed
- Ensure decision-makers attend formal meeting
- Document meeting outcomes:
- Draft minutes within 7 days
- Exchange with FDA for review
- Complete evaluation checklist
- Monitor compliance with agreements and notify FDA of any significant changes that could void agreements
- 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
Relevant Guidances
- Least Burdensome Principles for Medical Device Regulation
- Types of Communication During Medical Device Submissions Review
- Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program
Related references and norms
- 21 CFR 812.25: Requirements for investigational plans
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 summary file ID: 0cb0494612efcde51a6af791cc3f6b62
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