Virtually every device manufacturer that studies humans needs to determine whether an investigational device exemption is necessary.
With that in mind, device manufacturers should understand what an investigational device exemption is, to which devices it applies, and how to obtain an investigational device exemption if it is needed.
Let's start with the basics:
What is an Investigational Device Exemption?
An investigational device exemption allows an unapproved device to be used in clinical studies to collect data regarding its safety and efficacy.
It enables manufacturers to ship a device from one state to another when conducting clinical studies on the device without being subject to most other provisions of the Federal Food, Drug, and Cosmetic Act.
An investigational device exemption is required for all devices that pose a significant risk to the patient. Although a small percentage of the data may be used for devices being submitted under a 510(k) application, most of the devices that require an investigational device exemption are being submitted via the premarketing application.
An investigational device exemption may also be required for a legally marketed device that has been modified. Manufacturers must obtain an investigational device exemption before they start clinical studies on a device.
How to Apply for an Investigational Device Exemption for Devices That Pose a Significant Risk
Medical device companies are responsible for submitting an investigational device exemption and obtaining institutional review board approval for a clinical evaluation of device.
Foreign companies must have a sponsor in the United States to do so. Early communication can help the medical device corporation to determine whether an investigational device exemption is needed, so Medical device corporations are encouraged to contact the Food and Drug Administration early in the process.
To apply for an investigational device exemption, medical device companies should do the following:
1. Submit an investigational device exemption application to the FDA
After submitting an application, they should obtain approval for the study from the institutional review board.
As part of the institutional review board’s approval process, they should select appropriate investigators to conduct the study.
2. Submit an investigational plan and list of investigators to an institutional review board at each location where the study is going to be conducted
The investigators involved in the study should also be notified of the date when the FDA originally received the application.
If the device manufacturer hears nothing from the FDA after thirty days, they can assume that the investigational device exemption has been approved. They can then begin clinical studies on the device.
Submission Requirements for Medical Devices That Do Not Pose a Significant Risk
For devices that do not pose a significant risk, an investigational device exemption is not required.
However, medical device corporations should send the submission to and obtain approval from the applicable institutional review boards. In the submission, they should state why the device does not pose a significant risk.
If the institutional review board finds that the device poses a significant risk, the device manufacturer should inform the FDA within five working days of the decision. If the institutional review board concurs with the device manufacturer's assessment, the Food and Drug Administration will consider the device to have an approved investigational device exemption.
Requirements for Both Types of Devices
For both types of devices, the device manufacturer should label the device in compliance with the regulations.
This includes having a statement that the device is for investigational use. Medical device companies should only distribute the device to clinical investigators approved to be in the study.
They should make certain that subjects give informed consent before enrolling them in the study. Appropriate monitoring procedures should also be in place, adequate records should be kept, and appropriate reports should be made to the Food and Drug Administration, institutional review boards, and investigators.
They should adhere to the regulations regarding potential commercialization of a device, promotion of a medical device, and accurate representation of a device.
By understanding when an investigational device exemption is necessary and how to apply for it, device manufacturers can ensure that the clinical development of the devices that they seek to market proceeds smoothly.
This results in faster approval times and decreased delays in marketing a device.
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