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.”

The rule aims to help verify the accuracy of various clinical tests that doctors develop and use in labs. Califf pointed to the variations he saw while helping relatives with cancer.

“It just really disturbs me that you can go to different cancer centers and get entirely different answers based on which version of the test they happened to use,” he said.

Under the rule, lab test developers would be required to apply for FDA approval, beginning with higher-risk tests and phasing in over four years.

Some types of tests would be exempt, and the agency opted to roll back the initial proposal in several ways. Tests currently on the market would be grandfathered in, for example, and tests used within an integrated health system, the Department of Veterans Affairs or the Department of Defense would also be exempt. The FDA would also exempt tests verified through New York’s validation program.

The agency noted that it could revisit the exemptions in the future.

Currently, lab procedures are mostly regulated by the Centers for Medicare and Medicaid Services, but CMS does not validate the accuracy of the tests themselves. The FDA typically regulates testing devices like those used at home for pregnancy or COVID-19.

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