Background. OTC (over-the-counter, i.e. not requiring a prescription) rapid antigen covid-19 tests are the tests which detect pieces of viral proteins using lateral flow paper strips. Infected individuals with high viral load (i.e. individuals likely to spread the disease to others) are likely to get a positive result, while individuals without covid-19 are likely to get the negative one. The main roadblock for most companies trying to offer rapid antigen OTC at-home tests in the US is the struggle with getting FDA approval, caused by the "diagnostic" perspective of FDA. FDA has "OHT7: Office of In Vitro Diagnostics and Radiological Health, Office of Product Evaluation and Quality" called IVD office for short below but no office which looks at the tests from public health perspective, i.e. at the tests which can be used to prevent the spread to others. Given the existence of that roadblock, it is interesting to see that in this video at 1:59 a box of rapid antigen "tool" is shown labeled as "NOT-A-TEST". That motivates the following question.
The question. Assume a company wants to sell or give for free rapid antigen "tools" to regular US citizens in the US. These "tools" are intended to detect individuals more likely to spread covid-19 to others. The company does not have (such as approval or EUA) from FDA IVD office to do so. Can it still legally sell or give these "tools" (possibly by the virtue of modifying the labeling of such product)?
My research. I am not a lawyer, TINLA. Below I cite 21 USC section numbers, the correspondence between them and FD&C section numbers can be found here. It appears that the requirement to obtain the approval or EUA follows from the following:
- Such "tool" a device under 21 USC §321 (h) since it is intended for use in diagnosis, mitigation, or prevention of covid-19 in humans.
- Such "tool" is a class III device under 21 USC §360c (a),(f), since FDA/HHS did not issue any notices to the contrary and covid-19 tests did not exist before May 28, 1976.
- Such "tool" is in vitro diagnostic device, as defined in 21 CFR 809.3 (see also FDA's IVD FAQ and Congressional Research Service FAQ on covid-19 tests).
Thus, my guess is that a company intending to prove they do not need an approval / EUA from FDA's IVD office may want to do one of the following.
- Argue that the "tool" is intended to warn individuals to be more cautious regarding the spread of the disease to others, and not to improve their own health outcomes. Hence the "tool" is not intended for use in diagnosis, mitigation, or prevention of covid-19, and thus does not fall under the definition of 'device' in 21 USC §321 (h) and FDA's authority.
- Convince FDA to issue the De Novo classification of the "tool" as class I or class II device excepted from the requirements previously applied to covid-19 tests.
- Argue that, while the "tool" is a class III device, it is not an IVD device since it is intended to reduce the spread of covid-19 to others, not for the diagnosis or treatment of the person using the "tool". Thus, it should be excepted from the requirements previously applied to covid-19 tests.
I am not sure whether one of the above is a valid legal way to bypass the requirement, or whether there is some other way I am missing.