On diagnostics for COVID-19

  • FDA has issued an Immediately In Effect Guidance for laboratories and commercial manufacturers to help accelerate the use of test they develop in order to achieve more rapid and widespread testing capacity.  The guidance also provides FDA’s recommendations regarding validation of COVID-19 tests (see section V of the guidance).  The guidance can be found at the following link:


Other actions



  • FDA also announced that they would be taking steps to make more respirators, including certain N95s, available to health care personnel. Currently, the majority of respirators on the market are indicated for use in industrial settings. This action allows certain National Institute for Occupational Safety and Health (NIOSH) approved respirators not currently regulated by the FDA to be used in a health care setting by health care personnel during the coronavirus (COVID-19) outbreak, thereby maximizing the number of respirators available to meet the needs of the U.S. health care system.  https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-and-cdc-take-action-increase-access-respirators-including-n95s


FDA maintains a webpage dedicated to announcements and information related to COVID, which is updated daily.  It can be found at the following link:  https://www.fda.gov/emergency-preparedness-and-response/mcm-issues/coronavirus-disease-2019-covid-19