Current information on FDA actions in response to COVID-19

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:

https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-provides-more-regulatory-relief-during-outbreak-continues-help

• FDA maintains a listing of the tests that are authorized for COVID-19 testing on this webpage: https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations#coronavirus2019.   There are currently 9 FDA-authorized tests for COVID-19. Under the description of each test there are links to the FDA authorization letter, a package insert which describes the studies used to verify/validate the test and fact sheets for patients and physicians. 

Other actions

• FDA issued a guidance on conducting clinical trials during the pandemic to help industry and investigators navigate the COVID-19 pandemic and move forward with conducting clinical trials.

 

• FDA has issued a letter to healthcare providers with recommendations for conservation strategies of personal protective equipment (e.g. gowns and surgical masks) for use by healthcare organizations and personnel.  This letter can be found at the following link:  https://www.fda.gov/medical-devices/letters-health-care-providers/surgical-mask-and-gown-conservation-strategies-letter-healthcare-providers.  Also see: FAQs on Shortages of Surgical Masks and Gowns.

 

• 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