Format and Content of IDE Progress Reports

Recommended Actions

1. Establish a standardized template for IDE progress reports following the suggested format
2. Implement a tracking system for:
   • Investigator/site information
   • Subject enrollment
   • Device shipments
   • Adverse effects
   • Protocol deviations
3. Create a process for continuous risk assessment review
4. Develop a system to monitor and document manufacturing and quality control changes
5. Maintain a publication tracking system for study-related articles
6. Set up a timeline for PMA/510(k) submission planning
7. Establish a process for reviewing and documenting investigation plan changes
8. Create a standard operating procedure for progress report preparation and submission

Key Considerations

Clinical testing

• Number of investigators/investigational sites must be reported with a list of investigators
• Number of subjects enrolled (by indication or model) must be tracked
• Brief summary of study progress in relation to the investigational plan
• Summary of anticipated and unanticipated adverse effects
• Description of investigator deviations from the investigational plan

Non-clinical testing

• Include any new preclinical data and animal studies that may affect risk analysis
• Report foreign data that could impact risk assessment

Safety

• New adverse information affecting risk analysis must be reported
• Updated risk analysis if necessary based on new information
• Track and report number of devices shipped

Other considerations

• Changes in manufacturing practices and quality control must be summarized
• Changes to the investigational plan not requiring supplemental applications must be reported
• Progress toward product approval with projected submission dates
• Future plans for investigation changes must be mentioned
• Published articles from study data must be included

  Relevant Guidances

• Early Collaboration Meetings for Medical Device Development: Determination and Agreement Procedures
• Changes to Investigational Device Exemption (IDE) Protocols and When FDA Approval is Required
• IDE Clinical Investigation Decision Process and Requirements
• Early Feasibility Medical Device Clinical Studies Including First in Human (FIH) Studies

Related references and norms

• 21 CFR 10.115: Good Guidance Practices

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Original guidance

• Format and Content of IDE Progress Reports
• HTML
• Issue date: 1996-05-31
• Last changed date: 2023-08-10
• Status: FINAL
• Official FDA topics: Medical Devices, Investigational Device Exemption (IDE), Premarket
• ReguVirta summary file ID: a980aa332c4e4501833f1266f8dd324d