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ARTICLE · 16 APRIL 2020

FDA Warns Against At-Home COVID-19 Testing Kits

Morrison Foerster
Morrison Foerster
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A number of startups announced they would begin selling at-home COVID-19 testing kits this week. These startups included:...

United StatesCoronavirus (COVID-19)

A number of startups announced they would begin selling at-home COVID-19 testing kits this week. These startups included: Carbon Health, a tech-enabled healthcare network that combines virtual and in-person care, Everlywell, a company that offers food sensitivity and various other home health tests, and Nurx, an app that delivers prescriptions and STI testing kits.

But the U.S. Food and Drug Administration (FDA) quickly responded, demonstrating that it is actively and aggressively monitoring the market for products with fraudulent COVID-19 claims, as we previously reported here.

In its March 20 statement, FDA directly warned consumers—and indirectly warned the startups—that it "has not authorized any test that is available to purchase for testing yourself at home for COVID-19." In other words, it "is beginning to see unauthorized fraudulent test kits that are being marketed to test for COVID-19 in the home." FDA suggested that the public health value of expanded

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Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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