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mem42 replied to the topic What is Risk-benefit analysis ? in the forum Risk Analysis for Medical Devices 6 years, 10 months ago
One of the factors is Assessment of the Benefits of Devices. In this assessment, the FDA takes into account the types of benefits that the device has on patient health as well as their satisfaction. The types of benefits can be assessed by evaluating the impact the device has had among the population, and its ability to help prevent a disease, identify if certain patients are more likely to respond, predict a disease or help to provide an early diagnosis. All this information is helpful to assess the extent of probable benefits.