FDA finalizes rule to increase oversight of lab tests

By Lauren Clason, CQ-Roll Call

WASHINGTON — The Food and Drug Administration on Monday finalized a rule to regulate most tests developed in a lab, in a move that observers expect will face legal challenges and prompt intervention from Congress.

The rule effectively reclassifies tests developed and performed in a lab as medical devices for the purposes of FDA regulation. It’s a controversial strategy, but in the wake of the testing debacle during the COVID-19 pandemic, the FDA is clearly done waiting for Congress to act.