Investigational Device Exemption (IDE)
FDA regulations apply to products meeting the definition of a medical device
. An IDE is an investigational device exemption (application). The IDE application allows an investigational medical device to be used in a clinical study for the purpose of collecting data on safety and effectiveness.
A. Determining if an IDE Application is Needed
To determine if an IDE application is needed for your clinical research or study, complete the IDE determination checklist (found under "IND/IDE").
B. Compiling an IDE Application
The FDA has set forth the content and format for an IDE application. To protect researchers and UC, HRPP staff must review IDE applications prior to submission to the FDA (per UC HRPP policy III.08) whenever a UC researcher is serving as Sponsor-Investigator (the person who both initiates an FDA
regulated study and has the regulatory responsibility; sponsor in this
roles is not related to funding). Also see definition according to 21 CFR 312.3(b).
If you have questions regarding compiling and maintaining an IND application, please contact Angela Braggs-Brown or Kareemah Mills.
C. IDE Application Approval Process
Following submission, the FDA will send the sponsor notification that the IDE application has been received and the date of receipt. FDA may accept the application, request additional information or modifications. An clinical investigation may begin after IRB approval and after 30 days from the date of receipt on the FDA acknowledgement letter, unless FDA informs the sponsor that it may not begin.
In certain cases, the proposed clinical investigation of a medical device may be exempt from the requirement to submit an IDE application. Exempt medical devices must still comply with abbreviated IDE requirements (21 CFR Part 812.2(b)) including those associated with labeling (21 CFR Part 801.1; 21 CFR Part 812.5; 21 CFR Part 809.10(c)) and monitoring (21 CFR Part 812.46).
D. Maintaining an IDE Application
Research must be conducted in compliance with FDA regulations as well as UC policies and procedures. Researchers must obtain both FDA approval of the IDE application, as well as IRB approval of the protocol. All aspects of the study are subject to auditing by the FDA, the UC IRB, and it's designees.