Format and Content of IDE Progress Reports

What You Need to Know? 👇

What is an IDE Progress Report and when is it required?

An IDE Progress Report is a mandatory submission for Investigational Device Exemption studies that provides FDA with updates on study progress, safety data, and any changes to the investigation. It’s typically required annually or as specified in the IDE approval.

What are the essential elements that must be included in an IDE Progress Report?

The report must include basic study information (IDE number, device name, sponsor details), study progress data (enrollment numbers, adverse events, protocol deviations), risk analysis updates, manufacturing changes, and future plans including projected approval timelines.

How should adverse events be reported in IDE Progress Reports?

Both anticipated and unanticipated adverse effects must be summarized, including cumulative data from study initiation. New adverse information since the last report that may affect risk analysis should be highlighted, including preclinical, clinical, and foreign data.

What manufacturing and quality control changes need to be reported?

All changes in manufacturing practices and quality control must be summarized, including those not requiring supplemental applications. This ensures FDA awareness of any modifications that could impact device safety or effectiveness during the investigation.

Can protocol deviations be reported in the Progress Report instead of separate submissions?

Yes, investigator deviations from the investigational plan since the last progress report should be described in the Progress Report. However, significant protocol changes typically require separate supplemental applications for FDA approval before implementation.

What future planning information should be included in IDE Progress Reports?

Reports should include progress toward product approval with projected PMA or 510(k) submission dates, and any plans to modify the investigation such as expanding study size, changing indications, or discontinuing portions of the study.

---

What You Need to Do 👇

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

---

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 ID: a980aa332c4e4501833f1266f8dd324d