Hospital Institutional Review Board (IRB) Approved Non-significant

30 - Hospital Institutional Review Board (IRB) Approved Non-significant Risk Devices (Rev. 198, Issued: 11-06-14, Effective: 01-01-15, Implementation: 01-05-15) Clinical trials for non-significant risk devices (devices which do not require an FDA- approved IDE) are the responsibility of the hospital’s IRB. While these devices do not require an FDA-approved IDE, many of the FDA-approved IDE requirements apply to these non-significant risk devices (e.g., they may not be legally marketed). Medicare contractors are responsible for making the coverage determinations on non-significant devices that are the responsibility of the hospital’s IRB. Contractors should apply the same coverage criteria, where appropriate, to these devices as are applied to FDA- approved IDE Category A and B IDE devices.