or an Investigational Device Exemption (IDE) in order to qualify for an OOPD grant?
Yes, an IND/IDE is needed except for medical foods that do not need premarket approval and medical devices that are classified as non-significant risk (NSR). Applicants studying an NSR device should provide a letter in the application from FDA’s Center for Devices and Radiological Health indicating the device is an NSR device. Protocols involving an approved drug that would otherwise be eligible for an exemption from the IND regulations must be conducted under an IND in order to qualify for funding under this program. The proposed clinical protocol should be submitted to the applicable FDA IND/IDE review division a minimum of 30 days before the grant application deadline. Be sure to indicate in the IND cover letter that you are applying for an orphan product grant. In order to qualify for programmatic/scientific review, the study protocol proposed in the grant application must be under an active IND or IDE (i.e., not on clinical hold).
