February 15, 2023

Significant Risk vs. Nonsignificant Risk Devices: What’s the Difference & Why Does It Matter?

In the US, there are three independent but also interdependent systems to categorize the risk a medical device poses.

Perhaps the best known is the classification system, i.e., Class I, Class II and Class III. A second system is the Software Documentation Level, i.e., basic or enhanced system (AKA the Software Level of Concern, i.e., Class A, Class B or Class C system). Finally, the third important but seldom talked about risk system is the Significant Risk (SR) vs. Nonsignificant Risk (NSR) system.

There is plenty of information available on the classification and software risk systems as well as SR devices, e.g., their regulatory requirements and the IDE process. However, there is much less available on how to handle an NSR device. Given that the vast majority of devices are NSR, what is a manufacturer of a NSR device to do?

Register for this webinar, presented by regulatory expert Michael Drues, to learn best practices to avoid timely and costly mistakes as well as creative ways to use the SR vs. NSR system to your advantage!

This presentation will use the case study approach to provide a detailed look at the SR vs. NSR risk system, including:
  • What is a significant risk (SR) vs. nonsignificant risk (NSR) device?
  • How does the SR vs. NSR system compare to the other systems of risk?
  • Who determines if my device is SR or NSR and how is the determination made?
  • Why does SR vs. NSR matter? What are the requirements of each?
  • If my device is SR, what do I do? If my device is NSR, what do I do?
  • When and how should you take my SR vs. NSR determination to the IRB(s) and/or FDA?
  • Does my device need a clinical trial? How are clinical trials different for SR vs. NSR devices?
  • How should I select clinical trial sites and IRB’s?
  • Is there a template for the SR vs. NSR determination?
  • Should I do a pre-submission meeting with FDA for an NSR device even though it’s not required?
  • What are the challenges for the future?

Register for the webinar

Significant Risk vs. Nonsignificant Risk Devices What’s the Difference & Why Does It Matter
Who should attend?
  • Regulatory Affairs Professionals & Management
  • Quality Professionals and Management
  • Clinical Professionals and Management
  • Medical Device Executives
Register Now  

Hosted by

Etienne Nichols

Medical Device Guru,
Greenlight Guru

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About Greenlight Guru

Greenlight Guru is the #1 provider of modern cloud-based solutions for the MedTech industry, helping companies bring life-changing products to market faster, more efficiently, and with less risk.

Greenlight Guru’s MedTech Suite provides quality management, product development, and clinical data management solutions, along with high-quality training and education required to keep up with the rapidly changing industry regulations.

Trusted by over 1,100 medical device companies across the globe, Greenlight Guru has been named by G2 as the #1 Medical QMS Software and by the Inc Magazine as a Best Place to Work.

Visit our homepage to learn more.

About Vascular Sciences

Vascular Sciences has been conducting seminars specifically geared toward medical device design, development and testing since 1996.

These seminars have been requested by companies ranging in size from start-up to fortune 100 companies, the European Patent Office and the FDA Centers for Devices and Radiological Health (CDRH).

Visit their website to learn more.

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