JD Supra Article - FDA Oversight of Laboratory-Developed Tests Continues To Evolve The JD Supra article “FDA Oversight of Laboratory-Developed Tests Continues To Evolve” reviews how FDA regulation of LDTs has shifted over decades and highlights the August 19, 2020 policy change stating LDTs would not face FDA premarket review absent formal rulemaking. It summarizes COVID-era FDA policies and the emerging role of Congress (including the VALID Act) in shaping a longer-term regulatory framework, underscoring ongoing uncertainty for laboratories and diagnostic developers. primary file regulatory ldts 2020-10-03_JD Supra Article - FDA Oversight of Laboratory-Developed Tests Continues To Evolve.md regulatory/ldts/2020-10-03_JD Supra Article - FDA Oversight of Laboratory-Developed Tests Continues To Evolve.md 2020_10_03 gdoc docx CC BY 4.0 - https://creativecommons.org/licenses/by/4.0/ 2077 2661 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