FDA WARNING_LETTER - Physician 360, Inc. - August 14, 2020

On October 5, 2020, the FDA issued a Warning Letter to Physician 360 for manufacturing and marketing unapproved devices: Physician 360 Rapid Strep Test, Physician 360 Rapid Flu Test, and Physician 360 COVID-19 Rapid Test.

The Physician 360 Rapid Strep and Flu Tests are marketed for at-home use by lay users, a use for which no legally marketed test exists. The FDA classified these as Class III devices requiring premarket approval (PMA). Since Physician 360 lacks approved PMAs or Investigational Device Exemptions (IDEs), these products are adulterated under 21 U.S.C. § 351(f)(1)(B) and misbranded under 21 U.S.C. § 352(o) for failure to notify the FDA of intent to introduce them into interstate commerce (510(k) requirement). Physician 360's argument that they are operating under previous 510(k) clearances is rejected because they modified the devices and changed their intended use to at-home testing by lay users, including relabeling. The FDA asserts Physician 360 is the manufacturer.

The Physician 360 COVID-19 Rapid Test is also offered for sale directly to consumers (individual healthcare providers) for self-use with capillary blood without FDA marketing