Investigational Device Exemption
Investigational Device Exemption - What is it?
The investigational device exemption (IDE) facilitates the utilization of the investigational device in a clinical study, enabling the collection of safety and effectiveness data. Typically, clinical studies serve as a foundation for supporting a PMA. Clinical data, however, is only required for a minimal percentage of 510(k) applications. Investigational use extends to the clinical evaluation of specific modifications or novel intended uses for legally marketed devices. For any clinical evaluation of investigational devices, unless exempted, securing an approved IDE is a prerequisite before initiating the study.
Investigational Device Exemption - What does it entail?
To conduct a clinical evaluation of devices lacking marketing clearance, several prerequisites must be met:
Firstly, an institutional review board (IRB) must approve the investigational plan. In cases where the study includes a significant risk device, FDA approval of the Investigational Device Exemption (IDE) is also essential.
Secondly, obtaining informed consent from all patients participating in the study is a crucial step.
Thirdly, it is necessary to provide labeling indicating that the device is exclusively intended for investigational use.
Moreover, rigorous monitoring of the study is imperative to ensure compliance and gather relevant data.
Lastly, maintaining the required records and submitting reports as mandated is an integral part of the clinical evaluation process.
Investigational Device Exemption - What's next?
An approved IDE allows lawful shipment of a device for conducting investigations without the need to comply with other requirements of the Food, Drug, and Cosmetic Act (FD&C Act) applicable to devices in commercial distribution. During the investigation phase, sponsors are not obligated to submit a PMA or Premarket Notification 510(k), register their establishment, or list the device. Additionally, sponsors of IDEs are exempt from the Quality System (QS) Regulation, except for the requirements related to design controls (21 CFR 820.30).
For a significant risk device study, a sponsor must submit a comprehensive IDE application to the FDA. While there are no pre-printed forms for an IDE application, it must contain specific required information. Within the application, the sponsor must demonstrate the belief that the proposed investigation’s risks to human subjects are outweighed by the anticipated benefits and the importance of the knowledge to be gained. Furthermore, the sponsor must establish the scientific soundness of the investigation and provide evidence suggesting that the proposed use of the device will be effective.
How can Patient Guard Help?
Patient Guard can assist you in this process by drafting documentation to support the IDE application.
Give us a call or complete our contact us form for a free consultation on how we can assist you in this process.