COVID-19: FDA Eases Approval Policy By Allowing LDT Use Under ‘Immediately In Effect’ Guidance
The US FDA on 29 February issued a new guidance giving the OK to labs with pending COVID-19 laboratory-developed tests (LDTs) to use them while they await the agency’s approval under Emergency Use Authorization. The agency issued the guidance quickly, taking the unusual step of forgoing a public comment period.
You may also be interested in...
The US Government Accountability Office reviewed how the FDA reviewed and monitored COVID-19 tests during the pandemic and found room for improvement. One particular concern was the lack of a straightforward policy on when enforcement discretion would be used.
Three lawyers tell Medtech Insight that the recent move by the US HHS to revoke the FDA’s authority to oversee laboratory developed tests extends to all LDTs, and not just those used to test for COVID-19.
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.