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 Office of Research Integrity and Compliance (ORIC) 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 ORIC Emory for assistance with determining IDE requirements, submitting the IDE application, or maintaining the IDE.

The Emory IRB website page on Emory Sponsors and Sponsor-Investigators includes information on IRB submission of S-I studies, including Continuing Review and amendments. When the IRB has identified a new study with an Emory investigator as S-I, the S-I will be referred to us for training about specific S-I responsibilities. The S-I will be requested to complete the Emory S-I IDE Responsibility Checklist:

Answers from the FDA to frequently asked questions about medical devices (PDF)
Information to help you understand the function and duties of a sponsor.

ORIC one-on-one consultations regarding the following topics:

Contact Us

If you have questions or would like to discuss topics related to device studies, please contact us ORIC Email.