The FDA has scheduled a public workshop on the “Framework for Regulatory Oversight of Laboratory Developed Tests” on January 8 – 9, 2015. The purpose of the workshop is to discuss FDA’s proposal for a risk-based framework for addressing the regulatory oversight of “laboratory developed tests,” a subset of vitro diagnostic devices intended for clinical use and designed, manufactured and used within a single laboratory. Among other things, the FDA will address LDT labeling considerations; clinical validity and intended use; enforcement discretion; adverse event reporting; quality system regulation; and procedural issues. The workshop registration deadline is December 12, 2014. FDA will accept comments related to the public workshop until February 2, 2015.
