First COVID-19 Breathalyzer Test Authorized By FDA

By |2024-03-14T09:59:25-04:00July 20, 2023|Pharmacy Law Blog|

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By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

On April 14, 2022, the U.S. Food and Drug Administration (FDA) issued an emergency use authorization for the first Covid-19 diagnostic test that uses breath samples. The test, made by Texas-based company, InspectIR Systems, is authorized for those patients 18 and older.

InspectIR expects to produce approximately 100 testing instruments per week, which can each be used to evaluate approximately 160 samples per day. At this level of production, testing capacity using the InspectIR COVID-19 Breathalyzer is expected to increase by about 64,000 samples per month, according to the FDA’s […]