IDE Development Toolkit

1. Determine Whether You Need an IDE: the Pre-IDE Process

Review the FDA Guidance titled Significant Risk and Nonsignificant Risk Medical Device Studies.  The 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.

Sponsors of an SR study are encouraged to contact FDA to obtain further guidance prior to the submission of an IDE application. This will be especially beneficial to new sponsors who have not previously had contact with the agency and for sponsors proposing to study new technologies or new uses for existing technologies. The pre-IDE Program is primarily designed to benefit the IDE sponsor.  By allowing the sponsor to obtain early FDA input on selected (by the sponsor) sections of the IDE application, FDA hopes that the initiation of clinical trials will be facilitated.

This communication may take the form of telephone conference calls, video conferences, or face-to-face discussions. The pre-IDE Program is intended as a way for sponsors to obtain preliminary comments on their pre-clinical data (bench/animal testing) or the investigational plan (clinical protocol) in a timely manner.  It will also allow FDA personnel to familiarize themselves with the new technologies.  The sponsor should contact the Office of Device Evaluation (ODE) reviewing division directly or may contact the IDE staff for assistance:

2. Complete the Study Protocol: An IDE Requires a Fully Developed Protocol

A fully developed protocol is the basis for both the IRB Application and the initial IDE submission:

1. Review the attached protocol template for required content.  A completed protocol must be included in the IDE application.
   66 kBStudy Protocol for a medical device study
2. Start with a protocol synopsis (page 7 and 8 of the protocol template).  The protocol synopsis will be valuable if you are planning a pre-IDE meeting.
3. Compile a reference list – include all published articles and unpublished reports or manuscripts cited.  Collect a copy of each article or report listed.

3. Prepare the Initial IDE Submission

1. The IDE Sponsor-Investigator compiles information in three broad areas:
   • Report of Prior Investigations: Published and unpublished reports of all prior clinical, animal, and laboratory testing of the device
   • Investigational Plan: A complete written study protocol
   • Manufacturing Information: A description of the methods, facilities, and controls used for the manufacture, processing, storage, and, where appropriate, installation of the device
2. The IDE Sponsor-Investigator writes the IDE in the format of the IDE Submission Template.
   32 kBIDE Submission
3. The IDE Sponsor-Investigator writes the IDE cover letter in the format of the IDE Cover Letter Template.
   22 kBIDE Cover Letter

4. File the Initial IDE & Receive an IDE Number

1. Prepare three copies of the submission, including the cover letter (the signed original and two photocopies):
   • Three-hole punched paper
   • Left-hand margin of 1.5″ to allow for binding into report covers
   • Submit in ACCO-like report covers (side bound, made of cover stock).  Label each report cover with a typed 2” x 4” shipping label:
     
     Initial IDE Application
     Sponsor-Investigator Name, MD
     Date of Submission
2. Retain a .PDF copy of the signed submission for your records.
3. On the outer packaging of the submission (e.g., the FedEx label), identify the contents: “Initial IDE Application,” “IDE Supplement,” “Waiver,” etc.   The same identification should appear in the “RE:” section of the cover letter.
4. Send the initial IDE application to:Food and Drug Administration
   Center for Devices and Radiological Health
   Document Mail Center – WO66-G609
   10903 New Hampshire Avenue
   Silver Spring, Maryland 20993-0002
5. Keep a copy of the courier Airbill.  Track the shipment on the courier website for confirmation of delivery.
6. File a .PDF copy of the delivery confirmation with the .PDF copy of the signed submission.
7. FDA will reply to the submission with an acknowledgement letter containing:
   • the date of receipt of the IDE application
   • the IDE number assigned to your application
   • the name of the project manager to address in future submissions under the IDE

   An IDE application is considered approved 30 days after it has been received, unless FDA informs the sponsor otherwise.
   An IDE may be approved, approved with conditions, or disapproved.  In cases of disapproval, a sponsor has the opportunity to respond to the deficiencies and/or to request a regulatory hearing under 21 CFR Part 16

5. Maintain the IDE: Supplemental Applications, Notifications, and Reports

IDE holders are responsible for submitting supplemental applications, notifications, and reports in accordance with 21 CFR 812.  All submissions should be submitted in triplicate to the project manager named in the IDE Acknowledgement Letter.  Additional information can be found in the sections of 21 CFR 8 linked below and in “Guidance on IDE Policies and Procdures.”

Supplemental Applications (§ 812.35)

IDE holders may wish to modify the study protocol or the device design during the course of a clinical study. Under 21 CFR 812.35 sponsors are required to:

• Obtain approval of a supplemental application prior to implementing a major change in the investigational plan (e.g., significant modifications in device design, changes in indication, study endpoint or statistical method)
• Provide a “notice of IDE change” within 5 working days of making a change that does not require FDA approval

Reports (§ 812.150)

IDE sponsor-investigators are required under 21 CFR 812.150 to submit the following reports:

• Unanticipated adverse device effects (UADE)
  A UADE is any serious adverse effect on health or safety, 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 application; or any other unanticipated serious problem associated with a device that relates to the rights, safety, or welfare of subjects.A UADE Report consists of a completed Form FDA 3500A and an analysis of the event in a cover letter, submitted 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
  Submitted to FDA and all reviewing IRBs and participating investigators within 5 working days after receipt of notice of the withdrawal of IRB approval of an investigation (or any part of an investigation)
• Withdrawal of FDA approval
  Submitted to all reviewing IRBs and participating investigators within 5 working days after receipt of notice of any withdrawal of FDA approval
• Current list of investigators with addresses
  Submitted to FDA every six months
• Progress reports
  Submitted to FDA and all reviewing IRBs at regular intervals and at least yearly.  A suggested format for the Progress Report can be found on the CDRH website.
• Recalls and device disposition
  Submitted to FDA and all reviewing IRBs within 30 working days after receipt of a request to return, repair, or dispose of any unit of an investigational device. The report must state why the request was made.
• A 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 for the Final Report can be found on the CDRH website.
• Use of a device without informed consent
  Submitted to FDA within 5 working days after receipt of notice of such use
• SR device determination
  Submitted to FDA within 5 working days after determination by an IRB that the device is a SR device and not an NSR device as the sponsor had proposed
• Other reports
  Accurate, complete, and current information about any aspect of the investigation upon request from FDA or the reviewing IRB

Links

• IDE Reports
• IDE Definitions and Acronyms

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