GESTIÓN EN SALUD PÚBLICA: Coronavirus (COVID-19) Update: FDA Posts New Template for At-Home and Over-the-Counter Diagnostic Tests for Use in Non-Lab Settings, Such as Homes, Offices or Schools

viernes, 31 de julio de 2020

Coronavirus (COVID-19) Update: FDA Posts New Template for At-Home and Over-the-Counter Diagnostic Tests for Use in Non-Lab Settings, Such as Homes, Offices or Schools

https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-posts-new-template-home-and-over-counter-diagnostic-tests-use-non?utm_campaign=072920_PR_FDA%20Posts%20New%20Template%20for%20At-Home%20and%20Over-the-Counter%20COVID-19%20Diagnostic%20Tests&utm_medium=email&utm_source=Eloqua

Coronavirus (COVID-19) Update: FDA Posts New Template for At-Home and Over-the-Counter Diagnostic Tests for Use in Non-Lab Settings, Such as Homes, Offices or Schools

Today, the U.S. Food and Drug Administration posted a new template for commercial developers to help them develop and submit emergency use authorization (EUA) requests for COVID-19 diagnostic tests that can be performed entirely at home or in other settings besides a lab, such as offices or schools, and that could be available without a prescription.

“The FDA continues to help facilitate innovation in test development, thereby enhancing Americans’ access to COVID-19 tests,” said FDA Commissioner Stephen M. Hahn, M.D. “The recommendations provided today are intended to help get tests to market that are simple enough to use at home, similar to a pregnancy test. We hope that with the innovation we’ve seen in test development, we could see tests that you could buy at a drug store, swab your nose or collect saliva, run the test, and receive results within minutes at home, once these tests become available. These types of tests will be a game changer in our fight against COVID-19 and will be crucial as the nation looks toward reopening.”