Significant Risk vs. Non-Significant Risk In Device Clinical Trials

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Clinical Trials
Clinical: MedTech
Compliance & Regulatory: MedTech
Guidelines & Standards
Risk Mitigation & Management
This Weekly Briefing delves in to the differences between Significant Risk and Non-Significant Risk when it comes to clinical trials for medical devices!

Watch as Assistant Director of Regulatory Affairs, Ellie Reynolds, breaks down how risk is classified for new devices and how these determinations impact clinical studies, such as the potential need for an Investigational Device Exemption (IDE) before initiating the trial.

Can't watch right now and rather read a quick summary? Here is a recap of what Grace shares in the video:

Hello. Ellie Reynolds here from the team at Proxima Clinical Research.

Today, we're discussing the difference between significant risk and non-significant risk medical device studies and why it's important that the distinction is made. You may have heard about FDA's Class I, II, and III risk levels for medical devices. Clinical trials also use a framework to classify studies that's based on significant and non-significant risk.

First, let's go over what these terms mean.

As the name implies, significant risk or SR refers to studies of investigational devices that present potential for serious risks to the health, safety or well-being of the patient or user, including providing life, supporting or sustaining functions. Because of this, SR devices require FDA approval of an IDE prior to initiation of a clinical study.

On the other hand, non-significant risk or NSR studies carry minimal risks or risks that are well known or well managed.

Examples of significant risk studies include trials where the device is implanted is used for sustaining human life, patient care decisions solely depend on the device, or the study otherwise present a potential for serious risk to the health, safety or welfare of the subject. Non-significant Risk studies may examine a diagnostic device's performance while patients continue to receive decisions made on the current standard of care.

Sponsors make an initial risk determination and present it to the Institutional Review Board or IRB for their review. Determining if your study is significant risk or non-significant risk impacts the level of regulatory requirements that you need to meet before the trial begins. For example, if the IRB determines a study to be SR, a sponsor must receive FDA approval of the study through an investigational device exemption or IDE before beginning a trial, must follow all IDE requirements and must periodically update FDA per the IDE regulations.

Trials assessed to be NSR, however, only require oversight from the IRB and follow abbreviated IDE requirements. Understanding the distinction between SR and NSR device studies is a key consideration for medical device developers early on, but it's only one step in a nuanced process. At Proxima, we specialize in providing expert guidance and support in navigating the intricacies of medical device development, regulatory compliance and the requirements of SR and NSR device studies.

Reach out to us at where one of our regulatory experts would be happy to assist you.