US FDA to roll back lab-developed test oversight rule following court decision

(Reuters) -The U.S. Food and Drug Administration will rescind a rule that tightened regulations for clinical laboratories and gave the agency more oversight of diagnostic tests developed by them, a document on the Federal Register showed on Thursday.

The rule will become official after it gets published on September 19.

This follows the United States District Court for the Eastern District of Texas’ decision to vacate the rule in March.

Last year, the Association for Molecular Pathology, a nationwide group of doctors and scientists involved in diagnostic testing, asked a court to block the rule.

AMP called it “a historically unprecedented power grab that will jeopardize the health of hundreds of millions of Americans” and impose tens of billions of dollars in new costs on laboratories.