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This document is a legal memorandum filed in the United States District Court for the Eastern District of Texas, addressing the motion for summary judgment concerning the regulation of laboratory-developed tests (LDTs) by the FDA. It argues that the FDA\'s Final Rule overreaches its authority and conflicts with existing regulations, particularly the Federal Food, Drug, and Cosmetic Act (FDCA) and the Clinical Laboratory Improvement Amendments (CLIA). The plaintiffs contend that the Final Rule...
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