FREE ON-DEMAND WEBINAR
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?