Trump Administration: Premarket Approval No Longer Needed For LDTs

FDA will no longer require premarket review for laboratory developed tests, including tests developed to diagnose COVID-19, HHS announced Wednesday (Aug. 19) . But laboratories may still voluntarily seek emergency use authorization for tests in order to gain protection from legal liability. HHS says the decision was made to keep unnecessary regulations from interfering with efforts to combat COVID-19, and is consistent with several of President Donald Trump’s executive orders, including Executive Orders 13771 (Executive Order on Reducing Regulation and...