Updated FDA Covid-19 testing guidelines disallow at-home sample collection

What frustrates me the most is that, even under emergency conditions, their public justification consists solely of raising the hypothetical that some patients might draw the wrong conclusions from these tests without even acknowledging the possibility that some could be harmed by being denied access to the tests. There is zero indication that the risks have been weighed against the benefits.

At least in non-emergency situations you could argue that the regulation forces the company to study and document the difference between how home and out-patient tests impact the patients. Then you can decide whether to allow the test using that information. But that information will clearly take weeks or months to obtain, and in an emergency we have to make our best assessment on what to do in the meantime. It's possible to harm a patient by giving them information that is subtle and difficult to interpret, but our prior has to be that, all else equal, the patient will usually benefit with more information than less!