Overview
After initial submission, the Sponsor-Investigator must submit three types of reports to FDA (and to the IRB, where noted) to maintain an IDE: IDE Supplements, IDE Reports, and IDE Amendments.
Step1
IDE Supplements (Protocol and Device Changes)
The FDA tracks requests for a new protocol, changes to the approved protocol, or changes to the device, such as device design or manufacturing change, as supplements.
Submission reasons tracked as Supplements include:
- Change in correspondent, manufacturer, or sponsor
- Change in design or manufacturing
- Change in informed consent or protocol
- 5-day notices
- Request for compassionate use, live case demonstration, or other deviation from approved protocol
- Expansion of study (patients and/or sites)
- Extension of time to respond to FDA letter
- Request for waiver
- Institutional Review Board (IRB) certification
- Request for Centers for Medicare and Medicaid Services (CMS) recategorization
- Notification of study suspended or resumed
- Acknowledgement and response to clinical hold
- Termination of study
- New study or protocol
Step2
IDE Reports
The FDA previously tracked IDE reports as IDE supplements. IDE reports are now tracked as a report and not as a supplement.
Submission reasons tracked as Reports include:
- Adverse Effect
- Final, Study Completed
- Annual Progress
- Interim Progress
- Semiannual Investigator List
- Failure to Obtain Informed Consent
- Compassionate Use Follow-Up
- Emergency Use
- Live Case Follow-Up
Step3
IDE Amendments
The FDA tracks any IDE submission sent as a response to deficiencies communicated in an FDA disapproval, approval with conditions, or deficient report letter as an IDE Amendment to that submission.
For example, if you receive an “approval with conditions” letter after you submit your original IDE, your response intended to address deficiencies in that letter will be logged in as an Amendment. (Previously, such a submission would be tracked as a Supplement).
Amendments may be submitted to Supplements and Reports, as well as to the Original IDE.
Submission reasons tracked as Amendments:
- Response to Disapproval
- Response to Approval with Conditions
- Response to Refuse to Accept
- Response to Report Deficient
- Voluntary Withdrawal by Sponsor
How to Submit IDE Updates to the FDA
- Your IDE submission cover letter should identify the reason for the submission. Use the submission reasons in the bulleted lists above.
- Your submission should only include one reason (for example, a request to modify the study protocol, a deficiency letter response, and an adverse event report are three different submission reasons)
- When responding to an FDA deficiency letter, include the date of the FDA letter to which you are responding as well as the original IDE, IDE Supplement or IDE Report number.
Additional FDA Guidance
- IDE Definitions (includes terms such as "significant risk device" and "unanticipated adverse device effect")
- IDE Records (required of Sponsors and Investigators)
- Sponsor's Responsibilities for Significant Risk Device Investigations
- Changes or Modifications During the Conduct of a Clinical Investigation; Final Guidance for Industry and CDRH Staff
- IDE reporting requirements can be referenced at 21 CFR 812.150