We’ve been seeing device studies off and on for years, but we still don’t fell like we’ve mastered all the regulatory ins and outs of studies that involve investigational devices. In trolling around the FDA’s website not long ago, we found a guidance that has a lot of good information about device studies and what the IRB needs to consider when reviewing such studies. The guidance also describes the study’s responsibilities are, and recaps who is responsible for making the initial determination of whether a device is significant risk or nonsignificant risk.
Please make note of this guidance and consider adding it to your bookmarks, so you’ll be able to refer to it easily the next time you’re assigned to review a device study.