Creators of laboratory developed tests (LDTs) for COVID-19 don’t need to notify the US Food and Drug Administration before taking the diagnostics to market, the Department of Health and Human Services (HHS) said in a 19 August announcement.
The statement says the FDA won’t impose premarket review on LDTs absent the formal notice-and-comment rulemaking process. The requirement can’t be set via guidance documents, website statements, compliance manuals and...