Investigational Device Exemption (IDE) Submission Checklist
Investigational Device Exemption (IDE) Submission Checklist
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|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| |Copies of all published and unpublished adverse information.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| |Summary of all other relevant unpublished information |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 Health |
| |Document Mail Center (HFZ-401) |
| |9200 Corporate Blvd. |
| |Rockville, MD 20850 |
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