IDE holders are responsible for submitting supplemental applications, notifications, and reports in accordance with 21 CFR 812. All submissions should be submitted in triplicate to the project manager named in the IDE Acknowledgement Letter. Additional information can be found in the sections of 21 CFR 8 linked below and in Guidance on IDE Policies and Procedures.
Supplemental Applications (§ 812.35)
IDE holders may wish to modify the study protocol or the device design during the course of a clinical study. Under 21 CFR 812.35 sponsors are required to:
- Obtain approval of a supplemental application prior to implementing a major change in the investigational plan (e.g., significant modifications in device design, changes in indication, study endpoint or statistical method)
- Provide a “notice of IDE change” within 5 working days of making a change that does not require FDA approval
Reports (§ 812.150)
IDE sponsor-investigators are required under 21 CFR 812.150 to submit the following reports:
- Unanticipated adverse device effects (UADE)
A UADE is any serious adverse effect on health or safety, any life-threatening problem or death caused by, or associated with a device, if that effect, problem, or death was not previously identified in nature, severity, or degree of incidence in the application; or any other unanticipated serious problem associated with a device that relates to the rights, safety, or welfare of subjects.A UADE Report consists of a completed Form FDA 3500A and an analysis of the event in a cover letter, submitted to FDA and all reviewing IRBs and investigators within 10 working days after the sponsor first receives notice of the adverse effect.
- Withdrawal of IRB approval
Submitted to FDA and all reviewing IRBs and participating investigators within 5 working days after receipt of notice of the withdrawal of IRB approval of an investigation (or any part of an investigation)
- Withdrawal of FDA approval
Submitted to all reviewing IRBs and participating investigators within 5 working days after receipt of notice of any withdrawal of FDA approval
- Current list of investigators with addresses
Submitted to FDA every six months
- Progress reports
Submitted to FDA and all reviewing IRBs at regular intervals and at least yearly. A suggested format for the Progress Report can be found on the CDRH website.
- Recalls and device disposition
Submitted to FDA and all reviewing IRBs within 30 working days after receipt of a request to return, repair, or dispose of any unit of an investigational device. The report must state why the request was made.
- A final report
For a significant risk device, the sponsor must notify FDA and all reviewing IRBs within 30 working days of the completion or termination of the investigation. The sponsor must also submit a final report to FDA and all reviewing IRBs and participating investigators within 6 months after the completion or termination of the investigation. A suggested format for the Final Report can be found on the CDRH website.
- Use of a device without informed consent
Submitted to FDA within 5 working days after receipt of notice of such use
- SR device determination
Submitted to FDA within 5 working days after determination by an IRB that the device is a SR device and not an NSR device as the sponsor had proposed
- Other reports
Accurate, complete, and current information about any aspect of the investigation upon request from FDA or the reviewing IRB