IDE Approval Process - Nonsignificant Risk Device Studies

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.

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.