STAT+: Texas judge strikes down FDA\u2019s plan to regulate lab-developed tests
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WASHINGTON \u2014 A federal judge in Texas squashed<\/a> the Food and Drug Administration\u2019s plan to regulate lab-developed tests on Monday, ruling in favor of lab trade groups that said the agency was overstepping its bounds.\u00a0<\/p>\n \u201cThe Court VACATES and SETS ASIDE, in its entirety, the FDA\u2019s Final Rule titled Medical Devices; Laboratory Developed Tests,\u201d the ruling reads. \u201cThe Court remands this matter to the Secretary of Health and Human Services for further consideration.\u201d<\/p>\n The FDA has always believed it has the power to regulate lab-developed tests as medical devices, but it has not exercised that authority historically. It was only under President Biden that the agency announced its plans<\/a> to actively regulate the tests, giving labs until 2028 to comply. The move came after Congress tried and failed<\/a> to give FDA more explicit authority in 2022.\u00a0<\/p>\n Continue to STAT+ to read the full story\u2026<\/a><\/p>\n<\/div>\n