What

The FDA regulations state that all clinical investigations of devices must have an approved IDE or be exempt from the IDE regulations.

Who

The FDA definition of a sponsor-investigator means an individual who both initiates and actually conducts, alone or with others, an investigation, that is, under whose immediate direction the investigational device is administered, dispensed, or used. The term does not include any person other than an individual. (21 CFR 812.3 (o))

The sponsor (sponsor-investigator) is responsible for submitting an IDE application to FDA and ensuring IRB review and approval are obtained. (21 CFR 812.40)

How

The following questions and resources serve as a guide to assist in the determining whether your study requires an IDE.

1. Is the study an investigation?

The FDA definition of an investigation means a clinical investigation or research involving one or more subjects to determine the safety or effectiveness of a device. (21 CFR 812.3 (h))

2. Is the product a Medical Device?

Refer to the following information to determine if your product meets the FDA definition of a medical device.

3. Is the study exempt from IDE regulations?

Refer to the following documents to determine if the device study is exempt from IDE regulations (no IDE required).

Note: IRB review and approval is required for exempt studies.

4. Is the device study classified as a Significant Risk (SR) or Nonsignficant Risk (NSR) study?

If the study does not meet the exemption criteria (21 CFR 812.2 (c)), the sponsor (sponsor-investigator) is required to make an initial assessment of whether the study is a Significant Risk (SR) or Nonsignificant Risk (NSR) device study. Below is an overview of the approval process for these types of device studies:

Significant Risk (SR) Study Approval Process:

  • Require IDE submission and FDA approval prior to study initiation
  • Require IRB review and approval prior to study initiation

Nonsignificant Risk (NSR) Devices Approval Process:

  • Only require IRB approval prior to study initiation. IDE submission and FDA approval is not required.
  • If the sponsor (sponsor-investigator) believes it is a NSR study, the study can be be directly submitted to the IRB for review.
  • If the IRB agrees with the NSR assessment, the study is an abbreviated IDE and must must comply with abbreviated IDE requirements (21 CFR 812.2 (b)).
  • If the IRB disagrees with the sponsor-investigator’s NSR assessment, the sponsor (sponsor-investigator) must report this to the FDA within 5 working days (CFR 812.150(b)(9)).

For detailed guidance on the SR vs NSR determination and IDE approval process, refer to the following information:

5. Not sure if your study is a SR or NSR device study?

The FDA can make the study risk or IDE exempt determination. When the FDA makes the SR/NSR or exempt determination, the FDA is the final arbitrator.

To learn more about the application process for an FDA significant risk (SR), nonsignificant risk (NSR) or exempt determination, submit a Research 411 ticket.

Additional Resources

FDA Q-Submission Program: The FDA offers a Q-Submission Program that provides sponsors (sponsor-investigators) the opportunity to receive feedback from the FDA regarding IDE submissions.

Cancer Clinical Trials Office (CCTO): The Cancer Clinical Trials Office (CCTO) provide IDE consultations. To request a consultation, contact Tiffany Drummond, tiffany.drummond@mssm.edu.

Questions

The Office of Research Services (ORS) provides IDE consultation services as well as templates to assist study teams with IDE and Q- submissions. To request a consultation and/or templates, please submit a Research 411 ticket.

IDE Submission

Assistance

The Office of Research Services (ORS) provides consultation services as well as templates to assist study teams with IDE and Q-submissions. To request assistance, please submit a Research 411 ticket.

The Cancer Clinical Trials Office (CCTO) provide IDE consultations. To request a consultation, contact Tiffany Drummond, tiffany.drummond@mssm.edu.

The Research Compliance Program provides regulatory guidance and education to research teams. For questions, contact Vivian.Mitropoulou@mountsinai.org or call (646) 605-7120.

Helpful Tips when Submitting

  1. Ensure that there is an MD on the protocol/study personnel.
  2. Ensure that the person who is administering the investigational agent is part of the protocol/study personnel and is credentialed to do so.
  3. Application Template – If you are using the IDE application templates, delete the instructions prior to submission.
  4. Make a copy of the submission and file it in the regulatory binder.

IRB and IDE Submission Timelines

The IRB and FDA IDE submission may be done in parallel.  A copy of the FDA  receipt of submission is required to be provided in the IRB submission.

Note: Studies cannot be initiated until the IDE is approved and IRB approval has been obtained.

IDE Review Process

FDA will notify the sponsor (sponsor-investigator) of the date of receipt of the IDE application. The FDA will conduct a review within 30 calendar days of this receipt date. For detailed information, refer to FDA Action on IDE Applications.

Resources

IDE Annual Reports and Other Reporting Requirements (21 CFR 812.150)

21 CFR 812.150 requires sponsor (sponsor-investigator) to submit the following reports:

  • Unanticipated Adverse Device Effects
  • Withdrawal of IRB Approval
  • Withdrawal of FDA Approval
  • Current List of Investigators
  • Progress Report (Annual Reports)
  • Recalls and Device Disposition
  • Final Report
  • Failure to Obtain Informed Consent
  • Significant Risk Device Determination
  • Other

Refer to the following documentation for specific guidelines:

Questions

To request assistance and/or progress report templates, please submit a Research 411 ticket.

 

IDE Modifications (Supplements) (CFR 812.35)

Refer to the following documentation for guidance on the changes in investigational plan that require prior approval:

Significant FDA Communications Must be Reported to NIH

When NIH funds any part of the clinical study involving an IND or an IDE, significant communications with FDA must be reported to NIH.  For more information, refer to the NIH Policy Guidelines.

Regulatory Binder (Essential Documents)

For information regarding the regulatory binder requirements for FDA regulated sponsor-investigator studies, click here.

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