FDA Guidance - Laboratory Developed Tests Small Entity Compliance Guide The FDA “Laboratory Developed Tests: Small Entity Compliance Guide” (June 25, 2024) explains how the May 6, 2024 LDT Final Rule makes explicit that IVDs are regulated as medical devices even when manufactured by a laboratory and outlines FDA’s staged phaseout of its general LDT enforcement discretion. It summarizes key compliance milestones from 2025–2028 (MDR/complaints; registration/labeling/IDE; quality system; then premarket review) and highlights targeted enforcement discretion categories such as 1976-type LDTs, NYS CLEP–approved LDTs, certain modifications to cleared tests, “currently marketed” IVDs offered as LDTs, and LDTs for unmet needs. primary file regulatory ldts 2024-06-25_FDA Guidance - Laboratory Developed Tests Small Entity Compliance Guide.md regulatory/ldts/2024-06-25_FDA Guidance - Laboratory Developed Tests Small Entity Compliance Guide.md 2024_06_25 pdf Public Domain 7143 10416 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