ACLA Website - ACLA Statement on LDT Proposed Rule Comments by FDA and CMS The ACLA statement responds to an FDA/CMS joint release on proposed LDT regulation by reiterating ACLA’s position that LDTs are not medical devices and that FDA’s proposed rule would harm patients and stifle diagnostic innovation. It emphasizes laboratories’ role in patient care and argues for a legislative approach developed with Congress and stakeholders rather than applying the medical device framework to LDTs. primary file regulatory ldts 2024-02-01_ACLA Website - ACLA Statement on LDT Proposed Rule Comments by FDA and CMS.md regulatory/ldts/2024-02-01_ACLA Website - ACLA Statement on LDT Proposed Rule Comments by FDA and CMS.md 2024_02_01 date converted 2024-06-03 website Public Domain 202 378 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