Webinar 3: A practical approach for analyzing benefit-risk of medical devices
In this month's webinar, we discuss 2 ways you can use evaluate the overall benefit-risk of your medical device and illustrate a holistic approach based on FDA guidance and case studies.
Dear colleagues, hello! 👋
We continue our monthly live webinar series this month with a focus on evaluating the overall benefit-risk of medical devices to satisfy the regulatory requirement of safety and effectiveness.
Here is an excerpt from this webinar - paid subscribers, please scroll down to access the full recording.
Our discussion focused on 3 key aspects of the overall benefit-risk evaluation:
Benefit-risk evaluation is a relative measure
Benefit-risk evaluation is not static; it can change during the lifecycle of a device
Benefits must outweigh the overall residual risk for a device to be considered safe
We discussed 2 practical approaches, including a holistic approach to assess the benefits and risks, and the overall benefit-risk as well as associated uncertainty. We illustrated this approach with examples of 3 different medical devices approved or cleared by the US FDA.
Here are some of the questions from the audience we discussed during the webinar:
What are the different parameters for evaluating benefits, risks and uncertainty?
Do you consider risk acceptability to be an indication of positive benefit-risk?
We can get comparable benefits of other devices, but how do we compare residual risk?
Is there a public database for real world data (RWD) that can be utilized for evaluating benefit-risk?
FDA does not review benefit-risk during post-market inspections. Notified bodies will review in the context of EU-MDR, and they may not find FDA guidance completely satisfactory. How best to manage the expectations of regulatory bodies in both pre- and post-market phase?