Texas Judge Deems Lab-Test Rule Outside FDA Authority

By Bonnie Eslinger · March 31, 2025, 10:24 PM EDT

A Texas federal judge on Monday vacated a new U.S. Food and Drug Administration rule that would have brought lab-developed tests under its regulatory authority as "medical devices," finding that the...

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Documents

Order

Case Information

Case Title

American Clinical Laboratory Association et al v. U.S. Food and Drug Administration et al

Case Number

4:24-cv-00479

Court

Texas Eastern

Nature of Suit

Other Statutes: Administrative Procedures Act/Review or Appeal of Agency Decision

Date Filed

May 29, 2024

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