Scores of Critical Lab Tests Fall Into a Regulatory Void. The FDA Is Trying to Close It.

After decades of intense debate and stalled legislation, the Food and Drug Administration has taken a critical step in overseeing a vast category of lab tests that reach patients without any federal agency checking to ensure they work the way their makers claim.

Among the tests that are not reviewed by the FDA: popular prenatal genetic screenings that ProPublica recently reported on, as well as certain cancer screenings and tests for rare diseases.

On Wednesday, a notice of the proposed rule was posted. This is the first concrete evidence that the FDA is preparing to apply its regulatory powers to these lab tests.

“A modern oversight framework that is specifically tailored to assuring tests work is critical to position ourselves for the future — whether it is preparing for the next pandemic or realizing the full potential of diagnostic innovation,” an FDA press officer said in a statement to ProPublica.

Peter Lurie, president and executive director of the Center for Science in the Public Interest, applauded the move. “It’s exciting to see the agency taking concrete steps to address this...