Device Studies

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.

IDE Support

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 compliance@emory.edu 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.

Answers from the FDA to frequently asked questions about medical devices are available here.  Information to help you understand the function and duties of a sponsor is available here.

One-on-one consultation and assistance with the following topics is available:

If you have questions or would like to discuss topics related to device studies, please contact us at (404) 727-2398 or compliance@emory.edu.