Special Considerations for Device Research: IDE, NSR (Nonsignificant risk) and IDE Exempt
The FDA regulations establish additional requirements on the part of the IRB for the review of studies using medical devices. Before reviewing research involving a device (or devices), the Board must identify and evaluate the regulatory status of the device(s), such as determining whether the device study qualifies as a Non-Significant Risk (NSR) Device study, a Significant Risk (SR) Device study, or whether the research use of the device is exempt from the IDE regulations.
If you believe the device is NSR and the Board agrees, then the Board may go on to review the research. However, if the Board disagrees, and finds the study to be SR, and there is no IDE assigned, it will provide the investigator and, if appropriate, the sponsor, with its finding. The sponsor is responsible for notifying the FDA of the Board’s SR determination. The Board will not review the research until the sponsor provides written proof that either the FDA has granted an IDE to the sponsor or that the FDA disagrees with the Board’s SR determination and has determined that the device is NSR. If the FDA has not responded to the IDE application, as described in FDA 21 CFR § 812.30, this proof may consist of a letter showing that an IDE application was submitted at least 30 days prior to the date on which the submission was forwarded to WCG IRB.
The submission form will prompt you to provide the appropriate, required documentation for review of research involving an SR device. In most cases, submitters should ensure WCG IRB receives a copy of the IDE letter that has not been redacted. Redacted IDE letters generally do not provide sufficient information for the Board. If the research is SR, The IRB requires proof of the IDE number at the time of submission. The Board will automatically consider the research to be SR.
If the participant must undergo a medical procedure as a part of the study, and that medical procedure is not one which the participant would otherwise undergo as part of their care regardless of the research, the Board must consider the risks associated with the procedure as well as the use of the device. If potential harm to participants could be life-threatening, could result in permanent impairment of body function, or permanent damage to body structure, the device should be considered SR.
If approved devices will be used as part of the research, each site may be asked to confirm that the device(s) they are using are being used within their approved labeling.