ACLA - LDT Complaint to FDA Court filing The Complaint to FDA – ACLA LDT Complaint is a federal court filing by the American Clinical Laboratory Association and member laboratories challenging the FDA’s 2024 Final Rule that classifies laboratory-developed tests as medical devices under the FDCA. It argues the rule exceeds FDA’s statutory authority, conflicts with CLIA’s established regulatory framework for laboratory services, and is arbitrary and capricious under the Administrative Procedure Act. The complaint seeks declaratory and injunctive relief to vacate the rule and prevent FDA from enforcing device regulations on professional laboratory testing services. primary file regulatory ldts 2024-05-29_ACLA - LDT Complaint to FDA Court filing.md regulatory/ldts/2024-05-29_ACLA - LDT Complaint to FDA Court filing.md 2024_05_29 pdf Public Domain 94535 142259 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