3 ms·
I would actually say it's a very good example. That no matter how tightly and strenuously we regulate the safety of a product, 100% safety is an unattainable g
by jcims 6y ago
I would actually say it's a very good example. That no matter how tightly and strenuously we regulate the safety of a product, 100% safety is an unattainable goal and that given sufficient benefit there is an acceptable level of risk of grave outcomes, including death. This is from a publication on the risk/benefit evaluation of new medical devices from the FDA:
Uncertainty – there is never 100% certainty when determining reasonable assurance of safety and effectiveness of a device. However, the degree of certainty of the benefits and risks of a device is a factor we consider when making benefit-risk determinations.
pg 11 - https://www.fda.gov/media/99769/download https://www.fda.gov/media/99769/download