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.

FDA Commissioner Robert Califf has repeatedly made comments to that effect, saying in February, “I wish Congress had, I don’t know how to say it, done its job, whatever.”

“Rulemaking is — I’m sure you know — is limited in what we can do,” he said. “But it’s a start.”