FDA WARNING_LETTER - modern allergy management llc - June 16, 2020

The FDA issued a Warning Letter to Modern Allergy Management dba Direct Med Solutions on June 17, 2020, following a review of their website, covid.directmedsolutions.com/fingerstick, on June 16, 2020. The company was found to be offering an unapproved and unauthorized "COVID-19 Fingerstick Test Kit" for at-home sample collection and serology testing, intended for the mitigation, prevention, treatment, diagnosis, or cure of COVID-19.

This product is deemed a device under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the "Act"). The FDA cited the product as adulterated under section 501(f)(1)(B) of the Act because the firm lacks an approved premarket approval (PMA) or investigational device exemption (IDE). It is also misbranded under section 502(o) of the Act for failure to notify the agency of intent to introduce the device into commercial distribution, as required by section 510(k). Additionally, the product is misbranded under section 502(a) due to unauthorized use of the FDA logo on their webpage, which falsely implies FDA endorsement.

The FDA requested immediate action to cease the sale of these unapproved products and to correct all cited violations. The company must email COVID-19-Task-Force-CDRH