Anytime COVID Test LLC – FDA Warning Letter, Apr 2, 2021

The FDA issued a Warning Letter to Anytime Covid Test, LLC, on April 13, 2021, after reviewing their websites (e.g., anytimecovidtest.com) on October 9, 2020, and April 2, 2021. The company was found to be offering a "Covid-19 Test Kit" for direct-to-consumer at-home use, which the FDA classified as a device under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the "Act").

The COVID-19 Test Kit was deemed adulterated under section 501(f)(1)(B) of the Act because it lacked premarket approval (PMA) or an investigational device exemption (IDE). It was also misbranded under section 502(o) for failure to notify the FDA of intent to introduce the device into commercial distribution, as required by section 510(k). Furthermore, the product was misbranded under section 502(a) due to false or misleading labeling, including the unauthorized display of the FDA logo and a "Clinical Trials Number" implying FDA approval or authorization.

The FDA requested immediate action to cease the sale of these unapproved, uncleared, and unauthorized products. The company was required to email COVID-19-Task-Force-CDRH@fda.hhs.gov within