Emergency Use Authorization

On May 4, 2020, the US Food and Drug Administration (FDA) updated its enforcement policy on antibody tests for COVID-19.  The revised policy requires developers of commercial antibody tests to submit a request for emergency use authorization (EUA) to FDA.  Under the previous policy, commercial test developers could distribute their tests without FDA authorization.  The change in policy reflects growing concerns over the reliability of antibody tests currently on the market.  The policy shift also suggests that manufacturers of medical supplies subject to relaxed enforcement policies during COVID-19 should monitor policy developments to confirm the regulatory status of their products.
Continue Reading FDA Updates Policy to Curb Unreliable COVID-19 Antibody Tests

The U.S. Food and Drug Administration (FDA) issued two Emergency Use Authorizations (EUA) for commercially distributed COVID-19 diagnostic tests at the end of last week.  The first authorization was issued to Roche Molecular Systems, Inc., for its cobas SARS-CoV-2 Test, and the second issued the following day to Thermo Fisher Scientific, Inc., for its TaqPath COVID-19 Combo Kit.  Both tests are for the qualitative detection of SARS-CoV-2, the virus that causes coronavirus disease 2019 (COVID-19). FDA granted the authorizations within 24 hours of receiving the requests.

CVOID 19; EUA
Continue Reading FDA Grants COVID-19 Diagnostic Emergency Use Authorizations, And Other Recent FDA Actions to Address COVID-19