An Investigational Device Exemption (IDE) is a request for authorization for an investigational device to be used in a clinical study of safety and effectiveness. This authorization must be secured prior to administration of 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 Office of Compliance can assist investigators, coordinators and the Emory research community 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 (404) 727-2398 or email@example.com for assistance with determination of IDE requirements, submission of the IDE application or maintenance of the IDE.
When the IRB has identified a new study as one having an Emory investigator as S-I, the S-I will be referred to the Office of Compliance for training about specific S-I responsibilities. The S-I will be requested to complete the Emory S-I IDE Responsibility Form.
- S-I IDE Responsibilities Form
- S-I IDE Responsibilities Form Continuing Review Update
- S-I IDE Responsibilities Form Multi-site Trials
One-on-one consultation and assistance with the following topics is available:
- IDE requirement determination
- IDE application submission
- Protocol review: Click here for NIH-FDA Clinical Trial Template for Phase 2 and 3 IND/IDE Studies
- Regulatory document review
- SOP development: Click here for sample SOPs
- Expanded Access (Emergency and Compassionate/Treatment Use)
- Reporting requirements
- IDE maintenance Click here for Progress Report Template
- Audit/FDA inspection preparation
If you have questions or would like to discuss topics related to device studies, please contact us at (404) 727-2398 or firstname.lastname@example.org.