Fairview Research Administration (FRA) facilitates the use of investigational devices within the Fairview system. Our role is to make sure your research study or device use meets regulatory requirements without creating additional burden.
IDEs are specific to clinical research trials. IDE use is normally part of a trial sponsored by the device manufacturer.
If there is no third party billing, and the sponsor is paying for the device use, no immediate action is needed. Once the study is IRB approved, FRA will follow up with the coordinator to receive additional information for our institutional investigational device log.
If third party billing is necessary, then the device must be reviewed by National Government Services (NGS) prior to use:
HDEs are not considered research, but still require IRB approval prior to device use. FRA will assist the physicians with the IRB submission if requested. All other issues pertaining to the device use should be managed as any other clinical device.
The physician is responsible for informing FRA of the planned humanitarian device use through phone (612-672-7690) or email (firstname.lastname@example.org).
An FRA staff member will contact the physician to provide more information and guidance for completing the IRB application.