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INVESTIGATIONAL DEVICE EXEMPTION APPLICATION

IDE Title

(if being used)

Date of Submission: MM DD, YY

Name of Sponsor-Investigator, MD

X Professor, Department

Institution Name

CONFIDENTIAL

TABLE OF CONTENTS

1.	NAME AND ADDRESS OF THE SPONSOR	1

2.	REPORT OF PRIOR INVESTIGATIONS	1

3.	INVESTIGATIONAL PLAN	1

4.	manufacturing INFORMATION	1

5.	EXAMPLE OF THE investigatOR AGREEMENT	1

6.	investigator CERTIFICATION	1

7.	IRB INFORMATION	1

8.	OTHER INVOLVED INSTITUTIONS	1

9.	DEVICE CHARGES	1

10.	DEVICE LABELING	1

11.	CONSENT MATERIALS	1

12.	ADDITIONAL INFORMATION	1

NAME AND ADDRESS OF THE SPONSOR

REPORT OF PRIOR INVESTIGATIONS

Report of prior investigations (§ 812.27). A report of prior investigations must include reports of all prior clinical, animal, and laboratory testing of the device. It should be comprehensive and adequate to justify the proposed investigation. Specific contents of the report must include:

a bibliography of all publications, whether adverse or supportive, that are relevant to an evaluation of the safety and effectiveness of the device

copies of all published and unpublished adverse information

if requested by an IRB or FDA, copies of other significant publications

a summary of all other unpublished information (whether adverse or supportive) in the possession of, or reasonable obtainable by, the sponsor that is relevant to an evaluation of the safety and effectiveness of the device

if nonclinical laboratory data are provided, a statement that such studies have been conducted in compliance with the Good Laboratory Practice (GLP) regulation in 21 CFR Part 58. If the study was not conducted in compliance with the GLP regulation, include a brief statement of the reason for noncompliance.

A suggested format for presenting the information in this section can be found here:

Initial IDE: Report of Prior Investigations

INVESTIGATIONAL PLAN

Attach the completed study protocol here or in a referenced appendix. A study protocol template can be found here:

Initial IDE: Study Protocol Template

manufacturing INFORMATION

A description of the methods, facilities, and controls used for the manufacture, processing, storage, and, where appropriate, installation of the device, in sufficient detail that a person generally familiar with good manufacturing practice can make a knowledgeable judgment about the quality control used in the manufacture of the device.

A suggested format for presenting the information in this section can be found here:

Initial IDE: Manufacturing Information

EXAMPLE OF THE investigatOR AGREEMENT

An example of the agreement to be entered into by all investigators to comply with investigator obligations stated under part 812, and a list of the names and addresses of all investigators who have signed the agreement.

Investigators CV should be attached as a part of this section. When 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; and a statement of the investigator's commitment to:

conduct the investigation in accordance with the agreement, the investigational plan, Part 812 and other applicable FDA regulations, and conditions of approval imposed by the reviewing IRB and FDA;

supervise all testing of the device involving human subjects; and

ensure that the requirements for obtaining informed consent are met

Investigator’s commitment to provide sufficient and accurate financial disclosure information and update information if any relevant changes occur during the investigation and for one year following the completion of the study.

investigator CERTIFICATION

A certification that all investigators who will participate in the investigation have signed the agreement, that the list of investigators includes all the investigators participating in the investigation, and that no investigator will be added to the investigation until they have signed the agreement.

IRB INFORMATION

A list of the name, address, and chairperson of each IRB that has been or will be asked to review the investigation and a certification of the action concerning the investigation taken by such IRB.

OTHER INVOLVED INSTITUTIONS

The name and address of any institution at which a part of the investigation may be conducted.

DEVICE CHARGES

State if device will be sold. If yes, please state the amount to be charged and an explanation of why sale does not constitute commercialization of the device.

DEVICE LABELING

Copies of all labeling for the device.

The labeling should contain the statement "CAUTION - Investigational Device. Limited by Federal (or United States) Law to Investigational Use." [§ 812.5(a))].

CONSENT MATERIALS

Copies of all forms and informational materials to be provided to subjects to obtain informed consent.

ADDITIONAL INFORMATION

Any other relevant information FDA requests for review of the application.

This is a good place to include the list any references you are attaching to the application.