Does my study need an IDE?
Studies testing the safety and/or effectiveness of a medical device are subject to the IDE regulations in 21 CFR 812. Studies meeting the IDE exemption criteria do not require an IDE. Studies that are not IDE exempt require either an abbreviated IDE (IRB oversight only) or an FDA-approved IDE depending on the risk level of the study (nonsignificant risk vs. significant risk). The IRB will determine if and what type of IDE is needed during the study protocol’s full board review, but ORAQ can provide a preliminary assessment of whether the study may meet any of the IDE exemption criteria or if a risk assessment by the IRB may be necessary. Alternatively, ORAQ can assist with submission of a study risk determination request for a binding assessment from FDA on whether the study requires an IDE.
Who puts together and submits the IDE?
A regulatory coordinator, the sponsor, another study team member, or an ORAQ Regulatory Affairs Scientist can take the lead on putting the Duke-sponsored IDE together; it’s up to the study team. It will be a collaborative process regardless of who leads the effort. However, even if ORAQ is not involved in drafting the IDE, per Duke School of Medicine policy, ORAQ must review and submit all Duke-sponsored IDEs and subsequent reports, supplements, and amendments to the FDA.
What is ORAQ’s role in device manufacturing and oversight?
ORAQ has a Regulatory Affairs team and a Good Manufacturing Practices (GMP) Quality team. While ORAQ is happy to help address questions from IDE sponsors on device manufacturing and quality expectations, ORAQ does not currently have dedicated resources to support quality oversight of medical device development or manufacturing. IDE sponsors are responsible for ensuring that the medical device is developed and manufactured in accordance with the applicable Quality System Regulations in 21 CFR 820. For investigational medical devices, the Design Control regulations in 21 CFR 820.30 apply. The IDE sponsor or a qualified delegate should review and store all documentation from the development and manufacturing processes along with any analytical testing. Please share manufacturing and testing information with the ORAQ Regulatory Affairs Scientist so that required information can be submitted to the IDE.
Please note that effective February 2, 2026, FDA’s Quality Management System Regulation will replace the current Quality System Regulation. More information on this change is provided here: https://www.federalregister.gov/documents/2024/02/02/2024-01709/medical-devices-quality-system-regulation-amendments
Should I submit to the FDA or IRB first?
Either way can work. If the Original IDE is submitted ahead of the IRB submission, the IDE approval letter from the FDA can be provided to the IRB in the initial submission. FDA may have edits to the protocol during Original IDE review, and this allows them to be incorporated prior to IRB submission.
There are some teams at Duke that choose to submit the study to the IRB ahead of the Original IDE submission—for example, they prefer to see all the IRB modifications to protocol/consent before providing to the FDA. However, in this situation, the IRB may hold up full approval of the study until they receive confirmation of an approved IDE.
What happens during FDA’s review of the Original IDE?
The original IDE has a 30-day review clock. The FDA will likely send information requests with a short turnaround time by email to the IDE sponsor during the review period, so the IDE Sponsor needs to be available and attentive to their email during this time. Please share any correspondence from the FDA with the ORAQ Regulatory Affairs Scientist supporting the project.
How are changes to the study or IDE handled?
Protocol amendments:
Changes to the protocol require one of the following: a) prior approval by the FDA, b) a 5-day notice submission, or c) can be submitted in the annual report. In general, prior FDA approval is required if the change affects a) the validity of the data or information resulting from the completion of the approved protocol, or the relationship of likely patient risk to benefit relied upon to approve the protocol; b) the scientific soundness of the investigational plan; or c) the rights, safety, or welfare of the human subjects involved in the investigation. FDA has a guidance document that gives examples of changes and their associated method for reporting to FDA. If prior approval by FDA is required, the review has a 30 day review clock. For amendments that don’t require prior approval from FDA, the change can be implemented following IRB approval. However, it is recommended that you make ORAQ aware of the amendment before IRB submission so that everyone is on the same page with the assessment and the appropriate reporting timelines can be met.
Changes and updates to device manufacturing information:
Please let the ORAQ Regulatory Affairs Scientist know about any manufacturing process changes or when new analytical data are available. The ORAQ Regulatory Affairs Scientist can help determine what information needs to be submitted to the IDE. Similar to protocol changes, manufacturing changes may need prior FDA approval or require a 5-day notice submission. FDA has a guidance document that gives examples of changes and their associated method for reporting to FDA. Please note that modifications that constitute a significant change in design or basic principles of operation, or that were not made in response to information gathered during the course of an investigation may not be made without prior approval of an IDE supplement.
When do I have to report adverse events to the FDA?
Unanticipated adverse device effects must be submitted to the IDE in addition to the IRB. “Unanticipated adverse device effect” means 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 (including a supplementary plan or application), or any other unanticipated serious problem associated with a device that relates to the rights, safety, or welfare of subjects.
The sponsor should report unanticipated adverse device effects to the FDA and all reviewing IRBs and participating investigators within 10 working days after the sponsor first receives notice of the effect. Please also loop in the ORAQ Regulatory Affairs Scientist ASAP for awareness.
What are my IDE annual report obligations?
An annual progress report must be submitted to the IDE by the anniversary of the approval date of the IDE. ORAQ’s REDCap database will send automatic annual report reminders starting 60 days before the IDE annual report due date and will continue to send reminders at 30, 7, and 0 days until the report has been submitted. ORAQ has an IDE annual progress report template and the ORAQ Regulatory Affairs Scientist can populate the template with known study information and provide the draft report to the study team. The study team will need to populate information on study progress including information on enrollment, number of devices shipped, results, adverse events, and deviations from the investigational plan. Please review the template on our website for more information on what data are required in the report.
Are any other IDE reports to the FDA required?
Per the IDE regulations, the IDE sponsor is required to submit to FDA a current list of the names and addresses of all investigators participating in the investigation every 6 months. However, FDA frequently waives this requirement in the IDE approval letter and only requires that the investigator list be submitted with the annual progress report. Please speak to your assigned Regulatory Affairs Scientist to determine the requirements applicable to your study.
The sponsor is also required to notify FDA within 30 working days of completion or termination of the investigation. The IDE sponsor must also submit a final report to the FDA and all reviewing IRBs within 6 months of study completion or termination. Please reach out to your assigned Regulatory Affairs Scientist if you are planning to close a study under an IDE so that the appropriate notifications and reports can be submitted.
Can ORAQ help answer IRB regulatory questions or make IRB submissions?
ORAQ does not assist with IRB submissions or questions. For questions regarding IRB requirements, please contact your Duke IRB specialist.
Does ORAQ help with FDA meeting submissions?
Yes, ORAQ supports Q-submissions and has extensive experience submitting pre-submission meeting requests for Duke-sponsored device projects. Pre-submission meetings are used to solicit feedback from the FDA on safety and performance testing requirements, preclinical and clinical study designs, potential predicate devices, and more. Please submit a Regulatory Affairs Service Request form or reach out to your assigned Regulatory Affairs Scientist if you’d like to have a meeting with the FDA for your device project. Per Duke School of Medicine policy, ORAQ must review and submit all Duke-sponsored FDA meeting requests.
Does ORAQ draft and submit device marketing applications (510(k)s, PMAs, etc.)?
As employees of a nonprofit research university, ORAQ’s focus is on supporting research rather than marketing applications. If you believe support of your marketing application is within Duke’s mission, please reach out to ORAQ@duke.edu or a member of the ORAQ leadership team for discussion.
Where can I find additional information on IDE requirements?
- ORAQ offers a Regulatory Affairs Training Program that gives an overview of premarket regulatory work related to drugs, biologics, and medical devices.
- ORAQ’s Education and Training page includes recordings of previous trainings like our IND and IDE workshops.
- ORAQ also has a recorded training course in the LMS on the sponsor responsibilities for IDEs. While the SOM requires the IDE holder to complete this, anyone at Duke can register and choose to take the course.
- The ReGARDD website has some educational information and resources for academic investigators.