Research Using Drugs or Devices
Any research involving a drug or device, whether FDA approved or not, requires IRB approval.
Drugs, drug combinations, or biological agents which have not been approved by the FDA may require an IND (Investigational New Drug) number from the FDA.
Devices which are not approved by the FDA or which are being studied for “off-label uses” require an IDE (Investigational Device Exemption) from the FDA, an IRB deemed IDE under 21 CFR 812.2 as a non-significant risk (NSR) device determination, or documentation from the FDA stating that the device is a NSR device.
More information about drug and device requirements may be found by contacting us or at the following links: