New Wild West on horizon as HHS allows COVID-19 lab-developed tests to bypass FDA 

HHS’s decision to exempt laboratory-developed tests for COVID-19 from FDA oversight could repeat the fallout from FDA’s short-lived policy to allow antibody tests on the market without regulatory review.

On Wednesday, HHS posted a notice on its website saying FDA can no longer require premarket review of LDTs for COVID-19 unless it goes through a formal rulemaking process. ...