{"id":15819,"date":"2020-04-16T08:10:51","date_gmt":"2020-04-16T13:10:51","guid":{"rendered":"http:\/\/www.paristn.net\/articles\/?p=15819"},"modified":"2020-04-15T23:50:44","modified_gmt":"2020-04-16T04:50:44","slug":"fda-coronavirus-covid-19-update-april-16th-2020","status":"publish","type":"post","link":"https:\/\/www.paristn.net\/articles\/2020\/04\/16\/fda-coronavirus-covid-19-update-april-16th-2020\/","title":{"rendered":"FDA Coronavirus (COVID-19) Update: April 16th, 2020"},"content":{"rendered":"

\"U.S.Silver Spring, MD<\/strong> – <\/span>The U.S. Food and Drug Administration (FDA) has announced the following actions taken in its ongoing response effort to the COVID-19 Coronavirus pandemic:<\/p>\n

The FDA issued two new emergency use authorizations<\/a> (EUAs) for serology tests to detect for the presence of coronavirus antibodies. The EUAs were issued to Ortho-Clinical Diagnostics, Inc.<\/a> for its VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack and Chembio Diagnostic Systems, Inc.<\/a> for its DPP COVID-19 IgM\/IgG System.<\/p>\n

\"Coronavirus\"<\/a>

Coronavirus<\/p><\/div>\n

The FDA issued an emergency use authorization<\/a> (EUA) for the emergency use of Stryker Instrument’s Sterizone VP4 Sterilizer1 N95 Respirator Decontamination Cycle for use in decontaminating compatible N95 and N95-equivalent respirators for single-user reuse by healthcare personnel.<\/p>\n

The FDA has posted a new “At-a-Glance Summary<\/a>” that captures the agency’s major activities in the fight against COVID-19 Coronavirus. The agency intends to regularly update this resource on efforts related to medical products and equipment, vaccines and therapeutics, food supply and more.<\/p>\n

Yesterday, the FDA issued guidance on digital health devices for treating psychiatric disorders<\/a> to help expand the availability of these devices while reducing user and health care provider contact and potential exposure to COVID-19 Coronavirus during this pandemic. The enforcement policy described in the guidance applies to computerized behavioral therapy devices and other digital health therapeutic devices for psychiatric disorders as well as low-risk general wellness and digital health products for mental health or psychiatric conditions.<\/p>\n

The FDA and Federal Trade Commission (FTC) issued a warning letter to one company for selling fraudulent COVID-19 Coronavirus products, as part of the agency’s effort to protect consumers. The seller warned, Earth Angel Oils<\/a>, offers essential oil products that are unapproved and misbranded drugs for the prevention and treatment of COVID-19 Coronavirus. There are currently no FDA-approved products to prevent or treat COVID-19 Coronavirus. Consumers concerned about COVID-19 should consult with their health care provider.<\/p>\n

Diagnostics update to date:<\/h3>\n