ACLA Website - ACLA Challenges FDAs Final Rule ACLA Challenges FDA’s Final Rule announces ACLA and HealthTrackRx’s May 29, 2024 lawsuit in the Eastern District of Texas contesting FDA’s May 6, 2024 Final Rule that treats laboratory-developed testing services as medical devices. It argues FDA lacks statutory authority because lab testing services are regulated under CLIA by CMS, and claims the rule is arbitrary and capricious under the Administrative Procedure Act and would disrupt patient access, costs, and innovation in clinical laboratory services. primary file regulatory ldts 2024-05-29_ACLA Website - ACLA Challenges FDAs Final Rule.md regulatory/ldts/2024-05-29_ACLA Website - ACLA Challenges FDAs Final Rule.md 2024_05_29 date converted 2024-06-03 website Public Domain 498 824 gfile-url xfile-github-download-url pdf-gdrive-url pdf-github-url github-markdown-url github-markdown-download-url web-pdf-url web-slides-url youtube-url web-url