On September 29, 2023, the Food and Drug Administration (“FDA”) announced the issuance of a Notice of Proposed Rulemaking (the “Proposed Rule”) to expand the FDA’s regulatory scope over in vitro diagnostics products (“IVDs”) to specifically address Laboratory Developed Tests (“LDTs”). Traditionally, the FDA exercised enforcement discretion over LDTs, meaning that the FDA has... READ MORE
A Whole New World for Laboratory Developed Tests – FDA Proposes End to Its Longstanding Policy of Enforcement Discretion
Posted on November 30, 2023 in Health Law News
Published by: Hall Render
