FDA Website - ACLAs Statement on the Final Rule ACLA’s Statement on the Final Rule responds to FDA’s April 29, 2024 Final Rule regulating laboratory developed testing services as medical devices and reiterates ACLA’s view that this approach will harm patient access and diagnostic innovation. It argues the rule will increase costs, limit availability of critical tests, and exceed FDA’s statutory authority, emphasizing that clinical labs are already robustly overseen and that any expanded FDA role should come through new legislation. primary file regulatory ldts 2024-04-29_FDA Website - ACLAs Statement on the Final Rule.md regulatory/ldts/2024-04-29_FDA Website - ACLAs Statement on the Final Rule.md 2024_04_29 date converted 2024-06-03 website Public Domain 308 475 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