FDA ISSUES EMERGENCY USE AUTHORIZATIONS(EUA)FOR COVID-19 DIAGNOSTICS,VENTILATORS AND SURGICAL MASKS

摘要

The FDA has taken actions to expedite the availability of medical supplies forthe COVID-19 pandemic COVID-19.9 The FDA has granted"Emergency Use Authorizations"for Diagnostics,Surgical Masks and Ventilators,and several tests can now be marketed without regulatory review.Further,the FDA has authorized state health agencies to oversee the validation and marketing of tests within their state without interaction with the FDA.The FDA has a"hotline"that test developers can call for immediate support.As of March 26,2020,there were 16 tests with EUAs.In addition,the FDA is granting EUAs for ventilators,anesthesia gas machines modified for use as ventilators,positive pressure breathing devices modified for use as ventilators,ventilator tubing connectors and ventilator accessories.EUAs are also being issued for respiratory protective devices such as surgical masks and face masks,including the authorized use of expired devices.These relief actions were deemed necessary in order to respond to the pressing public health emergency of COVID-19.