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manolo replied to the topic how far is "As Far As Possible" in the forum Risk Analysis for Medical Devices 6 years, 6 months ago
“As far as possible” to me would be to the point of common sense. Meaning, depending on the target product audience, there should be a level of intelligence that you expect the user to have. Take a tongue depressor for example. AFAP would be you assuming the user won’t try to swallow it. So the labeling on the package will say, “Do Not Swallow” or something to that extent. This is because you expect the average person to have the “common sense” to not try to swallow the depressor.
On the other hand, the average person has no idea what an electrical surgical unit is. So the target audience would surgeons. So you would come up with labelings that say, ” Do not use unless professionally trained” to cover the average person that decides to use it. On top of that, you would make other labels for the surgeons who are “trained” to use the device.