FDA Continues to Take Action Against Unapproved COVID-19 Tests

The FDA is continuing to warn firms that market unapproved products to treat or detect COVID-19 and said it is taking “urgent measures” to protect consumers from products that, without the agency’s approval or authorization, claim to mitigate, prevent, treat, diagnose, or cure COVID-19 in people.

Southlake, Texas-based Physician 360 received a warning letter related to COVID-19 rapid tests as well as rapid tests for influenza and streptococcal infection. The tests were being sold directly to consumers for at-home testing.

The FDA warned that the tests require premarket approval or an approved application for an investigational device exemption.