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
Changes requiring prior approval - most of the time, changes that are made in the Investigational Plan or Protocol and developmental changes in the device need to be pre-approved by FDA. FDA will review changes to an IDE that require prior approval within 30 days.
Changes requiring 5-day notice - these changes do not require prior approval, but notice must be provided to FDA within 5 working days of making the change, including changes effected for Emergency Use, non-significant changes in device design or manufacturing, certain changes to the clinical protocol that do not fit the criteria for prior approval (e.g., modifying secondary endpoints or modifying inclusion/exclusion criteria).
Minor changes - can be submitted in the annual progress report including minor changes in the following areas: the purpose of the study, risk analysis, monitoring procedures, labeling, informed consent materials, and IRB information.
FDA Guidance on Changes and Modifications external site (opens in a new window)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. For IDE reports, the FDA will respond to the sponsor-investigator within 30 days if the FDA has questions or requests for additional information; otherwise, the FDA may close the submission without issuing a formal response.
If a report is deficient, the sponsor-investigator's response to the deficiencies identified in the FDA's communication is designated as an amendment to that report.
Submission reasons tracked as Reports include:
- Unanticipated Adverse Device Effects
- Any serious adverse effect on health or safety or any life-threatening problem or death caused by, or associated with, a device if that effect, problem or death was not previously identified in nature, severity, or degree of incidence in the investigational plan or application (21 CFR 812.3(s) external site (opens in a new window) ).
- Report to the FDA within 10 working days.
- Withdrawal from IRB approval
- Report to the FDA within 5 working days.
- Deviation from Investigational Plan:
- Report to the FDA within 5 working days: The investigator must notify the sponsor and the reviewing IRB of any deviation from the investigational plan to protect the life or physical well-being of a subject in an emergency. If it is not an emergency, prior approval from the sponsor is required for changes in or deviations from the investigational plan.
- Prior FDA approval: If the change or deviation may affect the scientific soundness of the investigational plan or the rights, safety or welfare of the subject, the sponsor is required to obtain prior IRB approval and also to obtain FDA approval for a significant risk device investigation by submitting an IDE supplement.
- Final, Study Completed
- Annual Progress
- Interim Progress
- Submit if requested by FDA.
- Semiannual Investigator List
- Report every 6 months or annually with the IDE progress report, if FDA has granted a waiver of this requirement.
- Failure to Obtain Informed Consent
- Report to the FDA within 5 working days.
- Recall and Device Disposition
- Report to FDA within 30 working days after the request is made for an investigator to return, repair, or dispose of any unit of the device.
- 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
- A valid eCopy external site
(opens in a new window)
is required for original IDE applications and most IDE supplements, amendments, and reports.
- The eSubmitter-eCopies Tool external site (opens in a new window) is a program that guides you through the steps of creating an eCopy and allows you to download a formatted eCopy onto a local drive. This quick reference guide external site (opens in a new window) may be used as guidance.
- For detailed guidance, see the full eSubmitter User Manual external site (opens in a new window)
- Alternatively, you may review the FDA guidance on eCopy Program for Medical Device Submissions external site (opens in a new window) (April 2020), which provides technical standards for creating eCopies manually (review pages 17-29 carefully).
- Submitters can submit IDE applications, supplements, amendments, and reports external site (opens in a new window) online through the CDRH Customer Collaboration Portal (CDRH Portal): Send and Track Medical Device Premarket Submissions Online: CDRH Portal external site (opens in a new window)
- Your IDE update should include an FDA FORM 3514 external site (opens in a new window) cover sheet. The use of this form is optional. If you choose not to use the form, ensure that all relevant information is contained in a cover letter.
- 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 external site (opens in a new window) (includes terms such as "significant risk device" and "unanticipated adverse device effect")
- IDE Records external site (opens in a new window) (required of Sponsors and Investigators)
- Sponsor's Responsibilities for Significant Risk Device Investigations external site (opens in a new window)
- Changes or Modifications During the Conduct of a Clinical Investigation; Final Guidance for Industry and CDRH Staff external site (opens in a new window)
- IDE reporting requirements can be referenced at 21 CFR 812.150 external site (opens in a new window)