Investigational Device Exemptions

For clinical research studies directed at evaluating the safety and/or effectiveness of an unapproved device, the prior submission of an Investigational Device Exemption (IDE) is required if the reviewing institutional review board (IRB) determines that the device, or its proposed use in the research study, constitutes a “significant risk” to the research subjects.

  • A significant risk device is an investigational device that: (1) is intended as an implant and presents a potential for serious risk to the health, safety, or welfare of a subject; (2) is for use in supporting or sustaining human life and represents a potential for serious risk to the health, safety, or welfare of a subject; (3) is for a use of substantial importance in diagnosing, curing, mitigating, or treating disease or otherwise preventing impairment of human health and presents a potential for serious risk to the health, safety, or welfare of a subject; or (4) otherwise presents a potential for serious risk to a subject.

  • A “non-significant risk device study” is a study of a device that does not meet the FDA’s definition for a “significant risk device study.”

  • If a device is found to be a Non-Significant Risk device (NSR), an IDE application to the FDA for their approval is NOT required. A nonsignificant risk device study requires only IRB approval prior to initiation of a clinical study. Submissions for nonsignificant device investigations are made directly to the IRB of each participating institution. Sponsors should present an explanation to the IRB where the study will occur of why the device does not pose a significant risk. If the IRB disagrees and determines that the device poses a significant risk, the sponsor must report this finding to FDA within five working days [812.150(b)(9)]. FDA considers an investigation of a nonsignificant risk device to have an approved IDE when IRB concurs with the nonsignificant risk determination and approves the study.

  • An “implant” is defined by the FDA as “a device that is placed into a surgically or naturally formed cavity of the human body and is intended to remain there for a period of 30 days or more”.  The FDA may determine that devices placed into human subjects for shorter periods of time are also implants.

For Devices NOT Currently Approved for General Marketing by the U.S. Food and Drug Administration (FDA):

Exceptions to the general requirements for an IDE submission

  • Clinical research studies involving the use of an unapproved device may be exempt from the requirement for an IDE submission if the research is not being conducted for the purpose of determining the safety and effectiveness of the device and the research use of the unapproved device does not put the subjects at significant risk.
  • Clinical research studies of diagnostic devices are exempt from the IDE regulations if the testing:
  1. is non-invasive*;
  2. does not require an invasive sampling procedure that presents significant risk;
  3. does not by design or intention introduce energy into a subject; and
  4. is not used as a diagnostic procedure without confirmation by another medically established diagnostic product or procedure.

*The FDA defines 21 CFR 812.3 (k)) “noninvasive”, when applied to a diagnostic device or procedure, as “one that does not by design or intention: (1) penetrate or pierce the skin or mucouse membranes of the body, the ocular cavity, or the urethra; or (2) enter the ear beyond the external auditory canal, the nose beyond the nares, the mouth beyond the pharynx, the anal canal beyond the rectum, or the vagina beyond the cervical os.”  Blood sampling that involves simple venipuncture is considered noninvasive, and the use of surplus samples of body fluids or tissues that are left over from samples taken for noninvestigational purposes are also considered noninvasive.

  • If the use of the unapproved device in the research study involves greater than a minimal risk, the investigator is advised to seek clarification of the IDE submission from the FDA’s Center for Devices and Radiological Health.

For Devices Currently Approved for General Marketing by the U.S. Food and Drug Administration (FDA):  For clinical research studies directed at evaluating the safety and/or effectiveness of an approved device for an indication that does not appear currently in the FDA-approved product labeling (i.e., an “off-label” indication), the prior submission of an IDE is required if the reviewing IRB determines that the device, or its proposed use in the research study, constitutes a “significant risk” to the research subjects.

  • A “significant risk device study” is defined by FDA regulations as “a study of a device that presents a potential for serious risk to the health, safety, or welfare of a subject and (i) is an implant; or (ii) is used in supporting or sustaining human life; or (iii) is of substantial importance in diagnosing, curing, mitigating or treating disease, or otherwise prevents impairment of human health; or (iv) otherwise presents a potential for serious risk to the health, safety, or welfare of a subject.”
  • A “non-significant risk device study” is a study of a device that does not meet the FDA’s definition for a “significant risk device study.”

Devices Currently Approved for General Marketing by the U.S. Food and Drug Administration (FDA)Exception to the general requirements for an IDE submission.

  • Clinical research studies involving the use of an approved device for an "off-label" indication may be exempt from the requirement for an IDE submission if the research is not being conducted for the purpose of determining the safety and effectiveness of the device for this “off-label” indication and the research use of the device does not place the subject at a significant increase in risk (i.e., compared to the FDA-approved use of the device).
  • The prior submission of an IDE is not required for clinical research studies (e.g., product comparison studies) directed at evaluating the safety and/or effectiveness of an approved device for an indication that appears currently in the FDA-approved product labeling.
  • If the “off-label” use of the approved device in the research study involves greater than a minimal risk, the investigator is advised to seek clarification of the IDE submission requirements from the IRB or the FDA’s Center for Devices and Radiological Health.

If you would like to receive guidance in determining if an IDE is needed for your research study or to determine if your study is exempt from the requirement for an IDE submission, please contact Amanda Wood to discuss your research project and the potential need for an IDE.

CDRH Learn

The FDA's Center for Device and Radiological Health (CDRH) has developed several learning modules with regard to medical device regulations. These modules are intended as an interactive and accessible tool for those involved with medical device manufacturing and research. View website.