Do you have an investigational device ready for clinical study? Before testing in human subjects, you may need to apply for an Investigational Device Exemption (IDE) with the Food and Drug Administration (FDA). An IDE allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data.
During this COVID-19 disruption of workflow processes, the FDA is mandating electronic submission of IND/IDE related applications and materials. Each division has their own process for electronic submission. Please contact Sheila Austin by email at email@example.com for assistance with submission.
FDA Web Resources
- Medical Device Definition
- Medical Device Classes
- IDE Definition and Applicability
- Nonsignificant Risk (NSR) Devices
- Significant Risk (SR) Devices
- IDE Exempt Investigations
- IDE Approval Process
- IDE Responsibilities
- IDE Applications
- IDE Records
- Other IDE Issues
Billing Research Services in IDE Studies
If UF plans on billing items or services in an Investigational Device Exemption (IDE) study to subjects/insurance, the study must be pre-approved by the FDA and Medicare prior to study start-up.
For more information, see Pre-approval workflow for Investigational Device Exemption (IDE) Studies.
Who Can Help?
UF CTSI/OCR Research Project Navigators can assist with:
- Determination of product classification (i.e., drug vs. device vs. combination product vs.biologic)
- Applicability of an FDA Investigational Device Exemption (IDE)
- Assistance with submission of an IDE application
- Preparation, coordination, facilitation, and attendance at FDA meetings
- Preparation for regulatory support during FDA inspections of investigator-sponsored clinical trials
- Provide information about new guidance documents, inspection trends, inspection actions and new regulatory actions taken by FDA relating to IDE studies
- Sheila Austin, MS, CIP