Override: HHS Revokes FDA’s LDT Policies
The US department that oversees the FDA says the agency acted beyond its authority in asking labs to file emergency use authorizations, asserting that only CLIA rules should apply.
You may also be interested in...
HHS-wide update will address agency integrity improvements in the wake of concerns that political considerations inappropriately influenced regulatory decisions related to COVID-19 during the Trump Administration, the General Accountability Office notes in a new report.
A controversial Trump-era policy that blocked the US FDA from regulating laboratory-developed tests was binned by the Health and Human Services secretary on 15 November. As a result, the FDA will once again require emergency use authorizations or other clearances for new COVID-19 tests.
Experts say either would likely prioritize issues such as the coronavirus pandemic and the medical supply chain, but they would diverge in areas like laboratory developed test reform.