TIP Sheet INVESTIGATIONAL DEVICE EXEMPTION APPLICATION (IDE)
Tip #1: What is an IDE?An investigational device exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data. Investigational use also includes clinical evaluation of certain modifications or new intended uses of legally marketed devices. All clinical evaluations of investigational devices, unless exempt, must have an approved IDE before the study is initiated. First, find out if the study uses a Significant Risk (SR) or a non-Significant Risk (NSR) device using the decision tree on the COMIRB website. If you are using a SR device, your study will require both FDA and an Institutional Review Board (IRB) approval prior to initiation. FDA approval is obtained by submitting an IDE application to FDA.
Tip #2: What are required documents for the IDE application?
1. Investigational plan/protocol (§812.25)
2. Copies of all informed consent forms and all related information materials to be provided to subjects as required by 21 CFR 50, Protection of Human Subjects
3. IDE Cover letter with required information (see IDE_Cover_Letter)
4. IDE application form with required information (see IDETemplateContentFormatIDEApplication)
5. Investigator agreement form template (see IDETemplateExampleInvestigatorsAgreement)
6. Signed investigator agreements from each individuals involved in the research
7. FDA Form 3454 Certification: Financial Interest and Arrangements of Clinical Investigators for each staff member involved in the study (see CertFinInterest_Aug2012)
8. FDA Form 3455 Disclosure: Financial Interest and Arrangements of Clinical Investigators for each staff member involved in the study who has a significant financial interest (see DisclosureFinInterest_Aug2012)
9. CV of Primary Investigator
10. PMA and/or 510(k) documentation for device use in the study (if already FDA approved)
11. Product information/instructions for device to be used in the study (if already FDA approved)
12. Any other relevant information that FDA requests for review of the IDE application. Information previously submitted to FDA in accordance with Part 812 may be incorporated by reference.
13. FDA Form 3674 (CT.gov certification)
Tip #3: Are there other standard forms that need to be completed in addition to this documentation?
· No
Tip #4: How does the IDE package need to be submitted?
· Until further notice from the Office of Regulatory Compliance, all submissions need to be submitted to the FDA as hardcopies
Tip #5: What is the current mailing address?
Tip #6: Additional Information
· Have a naive reader proofread your submission
· 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.
· Sponsors of a significant risk device investigation must submit three (3) copies of a signed "Application for Investigational Device Exemption." That is, the cover page of your application should identify the submission as an application for investigational device exemption and the page should be signed by the sponsor.
· If the submission exceeds 2" in thickness, separate into volumes and identify volume number.
· 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.).
· All copies of each submission must be identical.
· Do not combine IDEs, PMAs and 510(k)s together; they must be separate submissions.
· 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. This will help to facilitate the review of your submission.
· Keep one copy for your own records, additional copies for other parties if needed (e.g. outside funding entity or company providing the investigational device for the study, COMIRB)
· If your project depends on external funding but funding is declined, withdraw the application
· FDA will notify the sponsor in writing of the date it receives an IDE application. FDA may approve, approve with modification, or disapprove an IDE application. FDA may request additional information about an investigation. The sponsor may provide the requested information or the sponsor may treat such a request as a disapproval of the application and request a hearing in accordance with 21 CFR 16.
The clinical investigation may begin after FDA and the IRB approves an IDE for the investigation. An investigation may begin 30 days after FDA receives the IDE application for the investigation of a device if IRB approval has been obtained unless FDA notifies the sponsor that the investigation may not begin.
Tip #7: For more information, go to:
http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM126418.pdf
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/InvestigationalDeviceExemptionIDE/default.htm
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/InvestigationalDeviceExemptionIDE/ucm046164.htm
http://devicewatch.org/reg/510k.shtml
or call the Clinical Research Support Center at (303) 724-1111