What does FDA recommend be included in the final report of the investigation from the sponsor to all reviewing IRBs (and to FDA for significant risk studies) (21 CFR 812.150(b)(7))?

A final report should be a basic scientific report of the studies conducted, including the results of testing the study hypotheses. This report can be a useful means of providing a simple account of the data collection and study outcome. Such a report can facilitate preparation of the eventual submission for regulatory action, particularly when accompanied by the information included in the investigational plan. The suggested format for the IDE final report, which FDA includes as an enclosure in all IDE approval letters, is found in Appendix 5 of this guidance. It should be noted that FDA will consider submission of a marketing application (510(k), PMA, or HDE) to serve as the final report for the IDE. When a study sponsor submits a marketing application in lieu of the final report, the sponsor should still submit a supplement to the IDE stating that the marketing application should be considered the final report for the study. The final report for significant risk device investigations must be submitted to the IRBs and/or FDA within six months after termination or completion of the study. 21 CFR 812.150(b)(7).