Watchdog Calls On FDA To Set Policy For Use Of Unauthorized Tests In Public Health Emergencies
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.
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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.
In further sign the agency is tightening oversight of EUA products, regulators have set up a Q&A web page for manufacturers explaining their responsibilities to report adverse events.
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.