Can you talk about what kinds of documentation the IRB should request when reviewing studies that include MR-PET scanners, MRI, etc? What about hybrid devices? What do we need to know?

Any clinical investigation of a device submitted to review at an IRB should provide clear documentation regarding the regulatory status of the device (IDE number, request for nonsignificant risk (NSR) determination, etc.). This would include clinical investigations of MR-PET scanners, MRIs, etc. The submission also should include any necessary supporting information needed to support the IRB’s review – such as device manuals, correspondence from FDA (if requested/required by the IRB), protocol, consent forms, and any other forms and documents required by the IRB or needing review. At Quorum, a standard device study submission should include:

1. The device study submission form (F-019) – this document informs the Board of the device status and you can request any determinations needed, such as a nonsignificant risk (NSR) determination;
2. The device manual;
3. All other standard submission documents (protocol, consent form, other submission forms). You should contact Quorum if you have any questions about unique issues related to your particular submissions.