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asn9 replied to the topic Risk management and Labels in the forum Risk Analysis for Medical Devices 8 years, 5 months ago
I would agree with Dr. Simon that it makes sense why labeling would not be considered a strong way to mitigate risk. While warning and instruction labels are important, it is also up to the company to ensure that the product’s risk is outweighed by the benefits. Ultimately, this topic falls under the ways in which risk is managed. I believe that if a risk cannot be removed, it does need to be labeled, but it should be done as a later resort.
-Andrew Nashed