What Is An Investigational Device Exemption Application and Study?

What Is An Investigational Device Exemption Application and Study?

Investigational Device Exemption Study

An Investigational Device Exemption (IDE) is an application submitted to obtain the FDA's approval for use of a novel medical device in a clinical study. This allows for the collection of safety and effectiveness data in order to support full market approval.

IDE applications support several types of studies: to determine early feasibility before a device's design has been finalized, traditional feasibility to capture safety and effectiveness data on near-final or final device design to plan for the pivotal study, and the pivotal study, which is designed to collect definitive evidence of a device's safety and effectiveness.

A critical part of an IDE is the proposed clinical study protocol. As stated by the FDA, clinical studies are usually conducted to support a Premarket Application (PMA) which allows for full approval to market Class III and some Class II devices. Investigational use encompasses the clinical evaluation of novel Class III devices, modifications or new proposed uses for some legally marketed devices (FDA, 2019). This blog outlines what an IDE application and study is and why it may be essential to legally market your medical device.

Why is an Investigational Device Exemption Application Required?

An IDE application is required to obtain the FDA's approval of clinical study protocol prior to executing a clinical study. A clinical study is required for Class III and some Class II medical devices to determine whether or not a medical device is safe and effective for broad human use.

Investigational devices are covered under IDE regulations based on the level of device risk. The risk levels are divided into two categories: significant risk (SR) and non-significant risk (NSR). For the below examples, we will discuss the FDA's regulatory requirements.

Significant Risk (SR)

Any device considered a significant risk (SR) must comply with the IDE regulations under 21 CFR 812, have an IDE application approved by the FDA, and Investigational Review Board (IRB) approvals before the investigation begins.

Non-Significant Risk (NSR)

Devices considered a non-significant risk (NSR) only need to adhere to amended IDE regulations under 21 CFR 812.2(b), and only IRB approval is required before the investigation starts.

It is also worth mentioning that devices can be exempt from IDE regulations under 21 CFR 812.2(c). Typically, a device is exempt if it is non-invasive and not used to conduct an invasive sampling procedure. Additionally, the final decision on which classification a medical device receives rests in the hands of the FDA; therefore, submitting the correct applications is essential. 

Why an Investigational Device Exemption Study is Important

An IDE study is carried out to ensure devices will not cause harm to human subjects when contact is made. The regulations set by the FDA and other regulatory bodies are set to maintain the safety of the device and those who come into contact with it.

Outputs of an IDE study include:

  • Evaluation of your device design concept with regard to initial clinical safety and device functionality
  • Provides first in-human data when there is no other non-clinical testing that can be performed
  • Captures preliminary safety and effectiveness data on near-final or final device design
  • Collects definitive evidence of safety and effectiveness for its intended use
  • Provides information and data needed to support full marketing approval

DS InPharmatics and Investigational Device Exemption Applications and Studies

DSI has a team of medical device experts with years of experience supporting companies that require assistance with medical device development and marketing approvals. This includes help with aspects such as device design, manufacturing, verification and validation and a deep knowledge of worldwide regulations including, but not limited to, ISO 13485 and the Medical Device Regulation 2017/745, FDA Title 21, CFR Part 820, SOR 98/282 (Canada), Therapeutic Goods Regulations (Australia), RDC 185/2001 (Brazil), PMDA (Japan) and NMPA registrations (China).

We aim to support our clients who require regulatory approvals. We do this by devising comprehensive strategies with our knowledge that has been developed over years of hands-on experience and an understanding of worldwide regulations Our services include, but are not limited to, the following options:

  • Medical Device Development Strategy
  • Worldwide Regulatory Submissions/Registrations
  • 510(K) – Medical Device Application
  • Investigational Device Exemption (IDE) Applications
  • Premarket Approval Application (PMA)

For more information on investigational device exemption studies or to discuss any of our services, please contact our team of expert consultants.

Meranda Parascandola
Meranda Parascandola
Meranda Parascandola is a member of the DSInpharmatics team and has written a variety of blog posts which you can read here.