united-states medical regulations fda
Can the need for FDA authorization of a tool to find infectious people be bypassed by labeling?
<p><strong>Background.</strong> OTC (over-the-counter, i.e. not requiring a prescription) <a href="https://en.wikipedia.org/wiki/Rapid_antigen_test" rel="nofollow noreferrer">rapid antigen covid-19 tests</a> 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 <a href="https://twitter.com/michaelmina_lab/status/1364251772190089219" rel="nofollow noreferrer">the</a> <a href="https://open.spotify.com/show/6b1EQELGQalA60gQnoIISj" rel="nofollow noreferrer">struggle</a> <a href="https://www.facebook.com/watch/live/?v=847585419419269&amp;ref=watch_permalink" rel="nofollow noreferrer">with getting FDA approval</a>, caused by the <a href="https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/vitro-diagnostics-euas" rel="nofollow noreferrer">&quot;diagnostic&quot;</a> perspective of FDA. FDA has <a href="https://www.fda.gov/about-fda/cdrh-offices/oht7-office-vitro-diagnostics-and-radiological-health-office-product-evaluation-and-quality" rel="nofollow noreferrer">&quot;OHT7: Office of In Vitro Diagnostics and Radiological Health, Office of Product Evaluation and Quality&quot;</a>  called <a href="https://www.fda.gov/medical-devices/products-and-medical-procedures/vitro-diagnostics" rel="nofollow noreferrer">IVD office</a> 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 <a href="https://youtu.be/wn80fTtO2I8?t=119" rel="nofollow noreferrer">in this video at 1:59</a> a box of rapid antigen &quot;tool&quot; is shown labeled as &quot;NOT-A-TEST&quot;. That motivates the following question.</p>
<p><strong>The question.</strong> Assume a company wants to sell or give for free rapid antigen &quot;tools&quot; to regular US citizens in the US. These &quot;tools&quot; 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 &quot;tools&quot; (possibly by the virtue of modifying the labeling of such product)?</p>
<p><strong>My research.</strong> I am not a lawyer, TINLA. Below I cite 21 USC section numbers, the correspondence between them and FD&amp;C section numbers can be found <a href="https://www.fda.gov/regulatory-information/federal-food-drug-and-cosmetic-act-fdc-act/fdc-act-chapter-v-drugs-and-devices" rel="nofollow noreferrer">here</a>. It appears that the requirement to obtain the approval or EUA follows from the following:</p>
<ul>
<li>Such &quot;tool&quot; a device under <a href="https://www.law.cornell.edu/uscode/text/21/321#h" rel="nofollow noreferrer">21 USC §321 (h)</a> since it is intended for use in diagnosis, mitigation, or prevention of covid-19 in humans.</li>
<li>Such &quot;tool&quot; is a class III device under <a href="https://www.law.cornell.edu/uscode/text/21/360c" rel="nofollow noreferrer">21 USC §360c (a),(f)</a>, since FDA/HHS <a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm" rel="nofollow noreferrer">did not issue</a> any notices to the contrary and covid-19 tests did not exist before May 28, 1976.</li>
<li>Such &quot;tool&quot; is in vitro diagnostic device, as defined in <a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?FR=809.3" rel="nofollow noreferrer">21 CFR 809.3</a> (see also <a href="https://www.fda.gov/medical-devices/ivd-regulatory-assistance/overview-ivd-regulation#1" rel="nofollow noreferrer">FDA's IVD FAQ</a> and <a href="https://crsreports.congress.gov/product/pdf/R/R46261" rel="nofollow noreferrer">Congressional Research Service FAQ on covid-19 tests</a>).</li>
</ul>
<p>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.</p>
<ul>
<li>Argue that the &quot;tool&quot; 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 &quot;tool&quot; is not intended for use in diagnosis, mitigation, or prevention of covid-19, and thus does not fall under the definition of 'device' in <a href="https://www.law.cornell.edu/uscode/text/21/321#h" rel="nofollow noreferrer">21 USC §321 (h)</a> and FDA's authority.</li>
<li>Convince FDA to issue the De Novo classification of the &quot;tool&quot; as class I or class II device excepted from the requirements previously applied to covid-19 tests.</li>
<li>Argue that, while the &quot;tool&quot; 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 &quot;tool&quot;. Thus, it should be excepted from the requirements previously applied to covid-19 tests.</li>
</ul>
<p>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.</p>

<h2>This is a <a href="https://en.wikipedia.org/wiki/Duck_test" rel="nofollow noreferrer">duck</a></h2>
<p><a href="https://i.stack.imgur.com/dShR3.jpg" rel="nofollow noreferrer"><img src="https://i.stack.imgur.com/dShR3.jpg" alt="A duck" /></a></p>
<p>You can label it a chicken if you like but you won’t fool anyone who knows about ducks.</p>
<p>The FDA knows about diagnostic devices; calling it something else isn’t going to fool them.</p>
