Nonsignificant risk device

Nonsignificant risk devices are devices that do not pose a significant risk to the human subjects. Examples include most daily-wear contact lenses and lens solutions, ultrasonic dental scalers, and foley catheters.

A nonsignificant risk device study requires only IRB approval prior to initiation of a clinical study. Sponsors of studies involving nonsignificant risk devices are not required to submit an IDE application to FDA for approval. Submissions for nonsignificant device investigations are made directly to the IRB of each participating institution. Sponsors should present an explanation to the IRB where the study will occur of why the device does not pose a significant risk. If the IRB disagrees and determines that the device poses a significant risk, the sponsor must report this finding to FDA within five working days [§812.150(b)(9)]. FDA considers an investigation of a nonsignificant risk device to have an approved IDE when IRB concurs with the nonsignificant risk determination and approves the study.