A flying blog that I read posed the question “go or no go” meaning would a pilot fly the flight with the potential for bad weather (in a general aviation airplane from San Francisco to Seattle). The intent of this was to get people who responded to discuss the weather reports that were presented in the blog and that’s just what people did. But in doing this, virtually all of the responses were about the risk side of the equation but every risk management decision should weigh the risk benefit tradeoff. Thus, the benefit of flying your own plane is the enjoyment of flying and also getting to a destination but in this case, the risk of bad weather (and its consequences) was greatly increased with no gain in benefit, and flying commercially was a viable alternative.
I suspect that for in-vitro diagnostics, the other side of the risk benefit equation is also neglected. My sense is that …
FDA focuses more on risk than benefit. That is, many diagnostic assays provide important information to the clinician and outweigh the harm of assay error. Put another way, more people are helped by the assay information provided to the clinician than the people that are harmed by assay error.
POC assays are often evaluated more on benefit than risk. Most POC assays can also be performed in the laboratory, albeit not as fast but the POC assays usually have more error. Does the rapid result outweigh harm due to increased error? In the case of A1C, some say no.