Do I Need an IDE?

Is an Investigational Device Exemption (IDE) Required?

  • An IDE allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval (PMA) application or a Premarket Notification 510(k) submission to the FDA.
  • Clinical studies with devices of significant risk must be approved by the FDA and by an Institutional Review Board (IRB) before the study can begin.
  • Studies with devices of nonsignificant risk must be approved by the IRB only before the study can begin.

For guidance on how to assess the level of risk for your medical device, request a consultation from our team of experts.

Investigational Device Exemption

Pre-IDE Activities

  • For background information, review the FDA Guidance titled Significant Risk and Nonsignificant Risk Medical Device Studies.  This guidance document provides definitions and examples of Significant Risk (SR) and Nonsignificant Risk (NSR) studies.
  • The sponsor-investigator makes the initial risk determination for the proposed study and presents it to the IRB.  The IRB then reviews the sponsor-investigator’s risk determination and agrees or disagrees.  FDA is available to help the sponsor-investigator and the IRB in making the determination.  If needed, FDA is the final arbiter.

Before presenting your risk determination to the IRB, we highly recommend that you request a consultation from our team of experts. Click here for help.

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Content and Format of an IDE Initial Submission

IDE Application Required Elements

  • Name and address of Sponsor
  • Report of Prior Investigations
  • Investigational Plan
  • A Description of Methods, Facilities and Controls used for the manufacture, processing, packing, storage and installation of the device.
  • An example of the agreement to be signed by the investigators and a list of the names and addresses of all investigators. If desired, a request for a waiver of the requirement to submit a list of investigators names and addresses every 6 months should be included in the IDE application. If the waiver is granted, investigators names and addresses can be included in the Annual Report.
  • Certification that all investigators have signed the agreement, that the list of investigators includes all investigators participating in the study, and that new investigators will sign the agreement before being added to the study
  • A list of the names, addresses, and chairpersons of all IRBs that have or will be asked to review the investigation and a certification of IRB action concerning the investigation (when available)
  • The name and address of any institution (other than those above) where a part of the investigation may be conducted
  • The amount, if any, charged for the device and an explanation of why sale does not constitute commercialization
  • Copies of all labeling for the device
  • 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
  • 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.

The ICTR IND/IDE team can help you navigate these requirements by providing templates, examples and guidance documents, please click here to request help.

IDE Lifecycle Reporting

Required Reports – The following reports are required by FDA:

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As Necessary

Unanticipated Adverse Device Effects

  • The sponsor must report the results of an evaluation of an unanticipated adverse device effect to FDA and all reviewing IRBs and investigators within 10 working days after the sponsor first receives notice of the adverse effect.

Withdrawal of IRB Approval

  • The sponsor must notify FDA and all reviewing IRBs and participating investigators of the withdrawal of IRB approval of an investigation (or any part of an investigation) within 5 working days of receipt of the withdrawal of approval.

Withdrawal of FDA Approval

  • The sponsor must notify all reviewing IRBs and participating investigators of any withdrawal of FDA approval within 5 working days after receipt of the notice.

Recalls and Device Disposition

  • The sponsor must notify FDA and all reviewing IRB’s of any request that an investigator return, repair, or dispose of any unit of an investigational device. The notice must be made within 30 working days after the request is made and must state why the request was made.

Failure to Obtain Informed Consent

  • Sponsors must submit a copy of any report by an investigator of the use of a device without first obtaining informed consent. The report must be made to FDA within 5 working days after receipt of the notice of such use.

Final Report

  • For a significant risk device, the sponsor must notify FDA and all reviewing IRBs within 30 working days of the completion or termination of the investigation. The sponsor must also submit a final report to FDA and all reviewing IRBs and participating investigators within 6 months after the completion or termination of the investigation. A suggested format is provided below.  For a nonsignificant risk device, the sponsor must submit a final report to all reviewing IRBs within 6 months after completion or termination.

The ICTR IND/IDE team can help you navigate these requirements by providing templates, examples and guidance documents, please click here to request help.

Every 6 Months

Current List of Investigators

  • Every six months the sponsor must submit to FDA a current list of the names and addresses of all investigators participating in a significant risk device investigation. FDA may grant a request for a waiver that allows the sponsor to submit the current list as part of the Annual Report. This request for waiver must be included with the IDE application.

The ICTR IND/IDE team can help you navigate these requirements by providing templates, examples and guidance documents, please click here to request help.

Annually

Progress Reports (or Annual Reports)

  • At regular intervals and at least yearly, the sponsor must provide progress reports to all reviewing IRBs. For a significant risk device, the sponsor must also submit the progress report to FDA.

The ICTR IND/IDE team can help you navigate these requirements by providing templates, examples and guidance documents, please click here to request help.

FAQs

Click here for answers directly from FDA on a variety of issues related to Investigational Device Exemptions.