Device Studies
An Investigational Device Exemption (IDE) is a request for the authorization to use an investigational device in a clinical study of safety and effectiveness. This request should be secured before administering any new device that is not the subject of an approved Premarket Approval. An IDE may be required for a clinical investigation using a marketed device for a use other than the indications in the approved labeling.
The Research Integrity Office will assist you in determining which regulations apply to the research along with providing education and consultation regarding regulatory requirements, compliance obligations, and best practices for Sponsor Investigators. Please contact us at researchcompliance@emory.edu for assistance with determining IDE requirements, submitting the IDE application, or maintaining the IDE.
One-on-one consultations regarding the following topics:
- IDE requirement determination
- IDE application
- Protocol review: NIH-FDA Clinical Trial Template for Phase 2 and 3 IND/IDE Studies (DOCX)Regulatory document review
- SOP development: Sample SOPs (DOCX)
- Expanded Access (Emergency and Compassionate/Treatment Use)
- IDE Communications
- Audit/FDA inspection preparation
Contact Us
If you have questions or would like to discuss topics related to device studies, please contact us at researchcompliance@emory.edu.