‘Minor Updates’ to 2 Covid Test Guidances

FDA says it is making minor updates to two Covid-19 testing guidances to help ensure continued access to tests while encouraging the transition of the tests to traditional premarket review pathways. An agency notice says the two affected guidances are Policy for Coronavirus Disease-2019 Tests (Revised) and Policy for Evaluating Impact of Viral Mutations on Covid-19 Tests (Revised).

“The minor updates to these guidances reflect FDA’s intent for the two guidances to remain in effect for the duration of the declaration under section 564 of the Federal Food, Drug, and Cosmetic Act that circumstances exist justifying emergency use authorization of in vitro diagnostics for the detection of Covid-19, rather than the duration of the public health emergency determination under section 319 of the Public Health Service Act relating to Covid-19,” the notice says.

FDA says it also made minor edits to the viral mutations guidance to reflect current information about variants and actions the agency has taken since the guidance was first issued.