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Clinical Trials Resource Group

Clinical Trials Resource Group

Number4IDE Process: Submit an IDE

IMPORTANT: the clinical study of a new indication for an already marketed device falls under the IDE regulation.

IDE requirements:
• Study approved by an institutional review board (IRB). If the study involves a significant risk device, the IDE must also be approved by FDA;
• informed consent from all patients obtained and documented;
• the device is labeled “CAUTION- Investigational Device. Limited to investigational use only”
• Sponsor-investigator complies with monitoring requirements
• Records and reports are maintained

Some studies may be exempt from the IDE regulations (21 CFR 812.2(c)), if: 

1. a legally marketed device when used in accordance with its labeling,
2. a diagnostic device if it is:
         • noninvasive;
         • does not require an invasive sampling procedure that presents significant risk;
         • does not by design or intention introduce energy into a subject;
          • and is not used as a diagnostic procedure without confirmation by another medically established diagnostic product or procedure;
3.  consumer preference testing…of legally marketed device(s)
4. a device intended solely for veterinary use;
5. a device shipped solely for research with laboratory animals

How to file an IDE
If the IRB determined that the approval of the protocol with investigational device, the investigator will prepare and submit the IDE application to the FDA.The IDE submission includes:
• Cover Letter
• Application

Content of the Cover Letter:

1. A statement that this is an original IDE application
2. Device information: a brief overview of the device
3. Sponsor-investigator contact information;
4. Device manufacturer information;
5. Applicant information (who submits this application);
6. Other relevant information (e.g. prior discussions with the FDA)

Example of a Cover Letter

 Content of an IDE Application: 

1. Table of Contents
2. Report of prior investigations (including animal work)
3. Investigational plan
4. Risk analysis (in table format)
5. Description of the device
6. Monitoring procedures
7. Manufacturing information
8. Sponsor-investigator information, including CV;
9. IRB information;
10. Sales information;
11. Environmental impact statement
12. Labeling
13. Informed Consent materials
14. Other information as pertinent

Use this IDE Template to generate IDE Application. The template expands each section in greater details.

Suggested format for IDE submissions

• Use paper with nominal dimensions of 8 1/2" by 11".
• Use at least a 1 1/2" wide left margin to allow for binding into jackets.
• Use 3-hole punched paper to allow for binding into jackets.
• Clearly and prominently identify submission as original IDE application or, for additional submissions to an IDE application, clearly identify the FDA assigned document number (e.g., G960000) and the reason for the submission (e.g., amendment or supplement) and the type of submission (e.g., Response to FDA letter; Addition of New Institution, etc.).
• Make 3 identical copies of each submission
• Unless the IDE sponsor has provided authorization in writing for another person to submit information on the sponsor's behalf, only the IDE sponsor may amend, supplement, or submit reports to the IDE.
• Sequentially number the pages, providing a detailed table of contents, and use tabs to identify each section.

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