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.
Investigational Device Exemptions (IDEs)
IDEs are specific to clinical research trials. IDE use is normally part of a trial sponsored by the device manufacturer.
To get started:
The researcher is responsible for informing FRA of the IDE study. You may do this in two ways:
- Populate the ‘IDE Number’ field in the TASCS Protocol screen. This automatically triggers an email to FRA.
- Email email@example.com at any point in the pre-award stage to inform FRA that a new IDE will be used in Fairview.
FRA is then responsible for asking: Will the device be billed to a third party?
- NO. 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.
- YES. The device must be reviewed by Noridian prior to use.
- Noridian is the Medicare Administrative Contractor that approves the billing of an investigational device to Medicare. This is a Medicare requirement.
- FRA will provide guidance for completing the required documentation, and will keep track of which requirements are still needed before the submission is complete. Once the application is complete, FRA will submit it to Noridian on behalf of the researcher.
- It is the researcher’s responsibility to provide all required documentation (see IDE Noridian Checklist below). Noridian only accepts complete applications, so FRA cannot move forward on a submission until we receive everything on the checklist.
- IDE Noridian Checklist
Humanitarian Device Exemptions (HDEs or HUDs)
HDEs are not considered research, but still require IRB approval and Noridian review prior to device use. FRA will assist the physicians with these two requirements. All other issues pertaining to the device use should be managed as any other clinical device.
To get started:
- 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 and Noridian application.
- IRB Application (see: http://www.research.umn.edu/irb/medical.html)
- HDE Noridian Checklist
Please note: Each provider and institution to use the device must be approved by Noridian. Please contact FRA if you are unsure if you are an approved user BEFORE using the device.