FDA Lacks Authority to Regulate Laboratory Tests, Judge Rules

A federal judge ruled Monday that the FDA doesn’t have the legal authority to regulate lab-developed tests, dealing a blow to the agency that has long sought to control tests in order to prevent inaccurate results and ensure quality products.

Judge Sean D. Jordan for the US District Court for the Eastern District of Texas said the Food and Drug Administration’s rule that allows it oversight of lab-developed tests exceeds its authority and is unlawful.

The FDA since the Biden administration has been battling a suit from the American Clinical Laboratory Association and the Association for Molecular Pathology over whether ...