Significant Risk vs. Nonsignificant Risk Devices - What's the Difference?

Do you understand the difference between significant risk and nonsignificant risk when it comes to the development and design of your medical devices? It’s important to classify devices properly, and the difference between SR and NSR is not always well-defined. Today, our guest will help medical device companies differentiate between these two classifications. Mike Drues, president of Vascular Sciences, has been a frequent guest on our show. He’s an expert in compliance, medical technology and regulatory compliances. Mike works regularly with the FDA, Canada Health, and other international regulatory agencies, and today he is sharing his insight on SR vs. NSR, as well as how this affects your development processes for your medical devices. Some of the topics you’ll hear about today include: - The difference between significant and nonsignificant risk, and how you can differentiate between the two. - Who decides whether a device has a significant or nonsignificant risk. (Hint: It’s not the FDA!) - Tips on analyzing, documenting, and finding experts to help you determine whether you are dealing with SR and NSR, as well as tips on notifying the FDA through the pre-submission process. - Information about the Institutional Review Board and how they are involved in the SR vs. NSR differentiation. - Thoughts on running clinical trials outside of the USA: advantages, disadvantages, and practicalities.