Perhaps silly to ask, but: why does the FDA regulate this?
It’s not a food, it’s not a drug, if it’s purely a saliva swab it is non-invasive — so where does the FDA come in?
In a university context, there is often a blanket IRB exemption for certain kinds of research where the risks are self-evidently minimal, such as taste tests.
If the FDA’s role here is to provide a stamp of approval indicating “this test ‘works’ according to an accepted standard,” then I would think something closer to how food supplements are monitored would be a better fit, for example, the test could come with text saying “this language has NOT been approved by the FDA” or equivalent for approval.
I am failing to see risks here besides the risks of misdiagnosis, but I just didn’t think it was the FDA’s mandate to approve or not approve based on efficacy.
It’s not a food, it’s not a drug, if it’s purely a saliva swab it is non-invasive — so where does the FDA come in?
In a university context, there is often a blanket IRB exemption for certain kinds of research where the risks are self-evidently minimal, such as taste tests.
If the FDA’s role here is to provide a stamp of approval indicating “this test ‘works’ according to an accepted standard,” then I would think something closer to how food supplements are monitored would be a better fit, for example, the test could come with text saying “this language has NOT been approved by the FDA” or equivalent for approval.
I am failing to see risks here besides the risks of misdiagnosis, but I just didn’t think it was the FDA’s mandate to approve or not approve based on efficacy.