Investigational Device Exemption (IDE) Submission Checklist



Investigational Device Exemption (IDE) Submission Checklist

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| |Copies of all published and unpublished adverse information.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| |Summary of all other relevant unpublished information |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 Health |

| |Document Mail Center (HFZ-401) |

| |9200 Corporate Blvd. |

| |Rockville, MD 20850 |

................
................

In order to avoid copyright disputes, this page is only a partial summary.

Google Online Preview   Download