FDA Warns Direct Med Solutions for Marketing Unapproved At-Home COVID-19 Test

The FDA has issued a warning letter to Direct Med Solutions in Milton, Fla., for selling adulterated and misbranded COVID-19 test kits for use at home.

The fingerstick test kit was marketed without approval, clearance or authorization and was misbranded because the firm didn’t notify the agency of its intent to market a product that requires a 510(k) application.

The agency said it is taking urgent steps to protect consumers from products that, “without approval, clearance or authorization by the FDA, claim to mitigate, prevent, treat, diagnose or cure COVID-19.”