ACLA Website - FDA Proposed Rule to Regulate LDTs Should Be Withdrawn The ACLA statement argues that FDA’s proposed rule to regulate laboratory-developed tests as medical devices should be withdrawn and summarizes ACLA’s submitted comments opposing the approach. It claims the rule would impose rigid device authorities on LDTs, reduce patient access to needed testing, slow innovation, and exceed FDA’s legal authority, while also criticizing FDA’s cost-benefit analysis as understating costs and overstating benefits. primary file regulatory ldts 2023-12-04_ACLA Website - FDA Proposed Rule to Regulate LDTs Should Be Withdrawn.md regulatory/ldts/2023-12-04_ACLA Website - FDA Proposed Rule to Regulate LDTs Should Be Withdrawn.md 2023_12_04 date converted 2024-06-03 website Public Domain 435 611 gfile-url xfile-github-download-url pdf-gdrive-url pdf-github-url github-markdown-url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