FDA Authorizes COVID-19 Breathalyzer Test

By: Emily H. Lineweaver

On April 14, 2022, the U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for InspectIR COVID-19 Breathalyzer, the first COVID-19 diagnostic test that detects the chemical compounds associated with a SARS-CoV-2 infection in an individual’s breath.  The InspectIR COVID-19 Breathalyzer test can be performed in a doctor’s office, hospital or mobile testing site by a qualified, trained operator who is supervised by a healthcare provider licensed or authorized by state law to prescribe tests. The instrument size is described to be “about the size of a piece of carry-on luggage,” and it can provide results in less than three minutes.

Emily H. Lineweaver
Emily Lineweaver is a member of the Firm’s Health Care Service team and concentrates her practice in the areas of health care and related litigation. Read More