Medical Devices that are the OBJECT of the study are listed in Section 16 of the IRB application with the appropriate FDA approval designation.
Devices that are NOT the OBJECT of the study should be described and referenced in the protocol document, the risk section of the application, and in the informed consent document, as appropriate. For example, if an ultrasound is performed as part of a research protocol, and is not the object of the study, but rather a procedure used for the research, it should be described in the protocol, risk section, and consent as necessary, but should not be included in Section 16.
If an “approved medical device used on label” is included in Section 16 of the IRB application, this section of the application itself provides questions which specifically ask if the medical device is the object of the study. As long as the study team indicates it is NOT the Object of the study, the medical device may remain in the application, but the IRBMED preference is that these types of devices not be listed in Section 16. We will not require its removal as long as it is appropriately designated.