FDA Clarifies Two COVID Test Policies In Effect Until End Of 564 Declaration

FDA on Thursday (Jan. 12) updated two of its COVID-19 test policies to clarify they will remain in effect throughout the duration of HHS’ so-called 564 emergency use authorization declaration, which gives FDA authority to issue EUAs during a public health emergency. The clarification comes amid speculation that HHS will not renew the COVID-19 PHE declaration when it expires in mid-April . HHS has renewed the PHE every 90 days since 2020. FDA has issued multiple policy guidances throughout the...