Investigational Device Exemption (IDE)

An Investigational Device Exemption (IDE) allows an investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval (PMA) application or a Premarket Notification [510(k)] submission to Food and Drug Administration (FDA).

  • Nonsignificant risk devices: the university's IRB board will review the application
  • Significant risk devices: the FDA and the university's IRB board will review the application

On this page:

Nonsignificant risk devices

  • Sponsors of studies involving nonsignificant risk devices are not required to submit an IDE application to the FDA for approval.
  • Submissions for nonsignificant devices are made directly to the IRB. Sponsors should present to the IRB an explanation 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 the FDA within five working days [§812.150(b) (9)].
  • The FDA considers an investigation of a nonsignificant risk device to have an approved IDE when the IRB concurs with the nonsignificant risk determination and approves the study.

Significant risk

A significant risk device poses a “potential for serious risk to the health, safety, or welfare of a subject.” Significant risk devices may include:

  • implants;
  • devices that support or sustain human life; and
  • devices that are substantially important in diagnosing, curing, mitigating or treating disease, or in preventing impairment to human health. 

Such devices may only be studied under an IDE granted by the FDA.  


Lynn Jagodzinski
(716) 888-4843

FDA's IDE process

The FDA has more information on the IDE process.

How do we complete an IDE?

A sponsor of a significant risk device study must submit a complete IDE application to FDA. There are no preprinted forms for an IDE application; however, an IDE application must include certain required information. The sponsor must demonstrate in the application that:

  • There is reason to believe that the risks to human subjects from the proposed investigation are outweighed by the anticipated benefits to subjects and the importance of the knowledge to be gained;
  • The investigation is scientifically sound; and
  • There is reason to believe that the device as proposed for use will be effective.

The following information must be included in an IDE application for a significant risk device investigation:

  • Information about the sponsor and investigators
  • Report of prior investigations
  • Investigational plan
  • A description of the methods, facilities and controls used for the manufacture, processing, packing, storage and installation of the device
  • A list of all IRBs that have reviewed the investigation and a certification of IRB action concerning the investigation
  • Information about where the investigation will be conducted
  • The amount, if any, charged for the device and an explanation of why sale does not constitute commercialization
  • Copies of all labeling for the device
  • Copies of all informed consent forms and all related information materials to be provided to subjects

Due to the amount and complexity of the data required for an IDE application, it can take several weeks to complete an IND submission. Therefore, we recommend you begin working on an IDE submission as early as possible.

Notes and additional references

If the use of the investigational device will take place in any of the Kaleida Health facilities (angiography suite, operating room, emergency department, clinic), the device MUST be built into Kaleida’s Lawson system for tracking and billing purposes regardless of who is supplying/paying for the device. The Clinical Research Office will facilitate the completion of the Product List Template for submittal to Kaleida’s Office of Research and Sponsored Projects. 

If use of the investigational device will take place at ECMC, the Clinical Research Application must be completed, reviewed and approved by ECMC’s Office of Clinical Research Coordination. 

The worksheet used by IRB reviewers to assess your IDE application is in the Click portal—IRB library section under the “Worksheets” tab. It is called “HRP-307-Worksheet-Device.” Reading this worksheet may help you understand the criteria and level of detail that the IRB and/or FDA need to make a determination.

Please find additional detail below: