IDE Process: IDE Annual Reports
At regular intervals, and at least yearly, a sponsor or sponsor-investigator has to submit progress reports to all reviewing IRB's. In the case of a significant risk device, a sponsor shall also submit progress reports to FDA. A sponsor of a treatment IDE submits semi-annual progress reports to all reviewing IRB's and FDA in accordance with 812.36(f) and annual reports in accordance with the section 21 CFR 812.150(5).
Sponsor or sponsor-investigator also prepares and submits the final report. In the case of a significant risk device, the sponsor or sponsor-investigator notifies FDA within 30 working days of the completion or termination of the investigation and submits a final report to FDA and all reviewing the IRB's and participating investigators within 6 months after completion or termination. In the case of a device that is not a significant risk device, the sponsor or sopnsor-investigator submits a final report to all reviewing IRB's within 6 months after termination or completion (21 CFR 812.150(7)).