ACLA - Letter to FDA - Comments on FDAs Proposed Regulation of LDTs as Medical Devices The American Clinical Laboratory Association’s December 4, 2023 letter submits formal comments opposing FDA’s proposed rule to regulate laboratory developed tests (LDTs) as medical devices. It argues that LDTs are professional laboratory services already subject to robust oversight under CLIA and state law, and that applying device regulation would reduce patient access, stifle diagnostic innovation, and exceed FDA’s legal authority. primary file regulatory ldts 2023-12-04_ACLA - Letter to FDA - Comments on FDAs Proposed Regulation of LDTs as Medical Devices.md regulatory/ldts/2023-12-04_ACLA - Letter to FDA - Comments on FDAs Proposed Regulation of LDTs as Medical Devices.md 2023_12_04 pdf Public Domain 49252 67421 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