Please check ()
1. Cover Letter
Statement that submission is an original IDE application
Sponsor Information (Name, Address)
Sponsor Contact (Name, Telephone Number, Fax)
Device Name and Intended Use
Manufacturer Information (Name, Address)
Manufacturer Contact (Name, Telephone Number, Fax)
If an investigation involves an exception from informed consent for emergency research, state in the Cover Letter that the investigation is subject to 21 CFR 50.24 requirements.
Other Information in Cover Letter (as appropriate):
Pre-IDE/Pre-IDE meetings: Describe your contacts with the FDA review division. If a Pre-IDE document was submitted, state the Pre-IDE number and name of FDA contact, if known, who reviewed the Pre-IDE. If a Pre-IDE meeting occurred, give name of FDA contact person and copy of meeting minutes.
Waiver Requests: Identify any requests for waivers and include a justification for the waiver.
Referenced Files: Identify any files by reference (for example, approved PMA, 510(k), IDE, Device Master File).
Note: If you are not the holder of these referenced files, include a letter from the holder of the files, which grants FDA permission to reference the files in its review of your current application.
2. Table of Contents
Provide a detailed Table of Contents page
3. Report of Prior Investigations
Report of all prior clinical, animal and laboratory testing
Bibliography of all relevant publications, whether adverse or supportive
Copies of all published and unpublished adverse information.
Summary of all other relevant unpublished information
Statement that non-clinical tests comply with 21 CFR 58, GLP regulation
Note: If any studies were not conducted in compliance with the GLP regulation, a brief statement of the reason for the noncompliance must be provided. Failure or inability to comply with this requirement does not justify failure to provide information on a relevant non-clinical test study.
4. Investigational Plan (Purpose)
Name and intended use of the device
Objectives of the investigation
Duration of the investigation (specify in months and years)
5. Written Protocol
Objectives, hypothesis or question to be answered
Description of type of study
Description of study conduct
Description of statistical methodology to be used
Case reports forms
6. Risk Analysis
Description and analysis of all increased risks to the research subjects
Manner in which risks will be minimized
Justification for the investigation
Description of patient population, including number, age, sex and condition
7. Description of the Device
Description of each important component, ingredient and property
Principle of operation of the device
Description of any anticipated changes in the device during the investigation
8. Monitoring Procedures
Written procedure(s) for monitoring the investigation
Name and address of the Monitor
9. Manufacturing Information– (methods, facilities and controls)
Manufacturing
Processing
Packing
Storage
Installation
Note: This section must provide enough information for FDA to evaluate the quality control of the device (e.g., that the device will meet the intended specifications).
10. Investigator Information
An example of an Investigator agreement
The Investigator's curriculum vitae
Where applicable, a statement of the Investigator's relevant experience (including the dates, location, extent and type of experience)
If the Investigator was involved in an investigation or other research that was terminated, an explanation of the circumstances that led to termination
Conduct the investigation in accordance with the agreement, the investigational plan, all applicable FDA regulations, and conditions of approval imposed by the reviewing IRB and FDA
Supervise all testing of the device involving human subjects
Ensure that the requirements for obtaining informed consent are met.
Certification that all participating Investigators have signed the agreement and that no Investigator will be added until the agreement is signed
Name and address of Investigators who have signed the agreement
11. IRB Information
Name, address and chairperson of each IRB
Certification of the action taken by each IRB, (i.e., approval)
Number of IRBs that have approved the investigation
Number of IRBs that are currently reviewing the investigation
Number of IRBs expected to review it in the future
Any other institutions not listed above but participating in the investigation
12. Sales Information
Statement as to whether the device is to be sold to Investigators
If YES, provide the amount to be charged
Explanation why sale does not constitute commercialization
Note: 21 CFR 812.7(b) prohibits the commercialization of an investigational device by charging subjects or Investigators for a device a price larger than necessary to recover costs of manufacture, research, development, and handling.
13. Labeling
Copies of all labeling for the device must be provided
Labeling must include the following:
- "CAUTION-Investigational Device. Limited by Federal (or United States) Law to Investigational Use."
- Adequate information for the purposes of the investigation, including the name and place of business of the manufacturer, packer, or distributor, the quantity of contents, and a description of all relevant contraindications, hazards, adverse effects, interfering substances or devices, warnings, and precautions
Labeling does not promote device as safe and effective for the investigational use
Note: 21 CFR 812.7(d) prohibits the representation of an investigational device as safe and effective for the purposes for which it is being investigated.
14. Informed Consent Materials
All informed consent forms contain required and appropriate optional elements
Copies of all forms and informational materials to be presented to subject included
15. Environmental Impact Assessment
Note: If applicable, you must make a claim for categorical exclusion from submission of an environmental assessment. If the product meets the exclusion requirements, state “I claim categorical exclusion under 21 CFR 34 (g), and devices shipped under the IDE are intended to be used for clinical studies in which waste will be controlled or the amount of waste expected to enter the environment may reasonably be expected to be nontoxic. To my knowledge, no extraordinary circumstances exist.”
16. Other Information
Note: Provide additional information supportive of the investigation and any information FDA has identified through previous contact or through guidance documents, as required.
17. Format
Use paper with nominal dimensions of 8 ½ by 11 inches
Use at least a 1½ inch wide left margin to allow for binding into jackets
Use 3-hole punched paper to allow for binding into jackets
If submission exceeds 2-inch thickness, separate into volumes, identify volume number
Clearly and prominently identify new submissions: “Original IDE application”
All copies of each submission must be identical
Note: Do not combine submissions
Provide a detailed table of contents
Sequentially number the pages, and use tabs to identify each section
State on the outside wrapper what the submission is: “Original IDE Application”
All submissions, in triplicate, should be addressed to:
Food and Drug Administration
Center for Devices and Radiological HealthDocument Mail Center (HFZ-401)
9200 Corporate Blvd.
Rockville, MD20850