Benefit Risk-Analysis: Learning From a Method Proposed by the FDA

In this video, we discuss the benefit-risk analysis of medical devices. This topic is very important, but also very challenging due to the lack of clarity and specific guidance on how to exactly perform a benefit-risk analysis.
This topic relates back to our recent Q&A regarding the benefit-risk analysis. Within this video, more detailed and actionable information will be provided that you can consider applying to your own system.
Read the FDA Analysis: www.fda.gov/me...
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[@kishorkaniche977]

Really like the presentation and efforts to team and share us knowledge, benchmarking benefits analysis and linkage with risk level can be studied like we can apply that mechanism to all devices if possible

[@fuxafak]

So, that means FDA would allow us to take the risk of killling 1 in 1000 if others lose significant weights ? Actually, who and when will decide that numbers? Is it kind of estimation before market, and live data at post-market? If more people get injured or damaged, then we should reconsider the risk analysis again.
By the way, thank you so much for all of your videos :)

[@NaveenAgarwalPhD]

You are correct that benefit-risk is evaluated given the available information at the time of pre-market approval. You can refer to the FDA guidance referenced in this video. You are also correct that FDA's assessment may change in the post-market phase if the actual real-world safety performance is worse than the pre-market assessment.

[@saugatluitel9753]

Thank you sir