On July 19 & 20, the FDA will sponsor a public meeting on Laboratory Developed Tests (LDTs). The meeting announcement says, “Since the implementation of the 1976 Medical Device Amendments, the FDA has generally exercised enforcement discretion and not enforced applicable regulations with respect to LDTs, a class of in vitro diagnostics (IVDs) that are manufactured, including being developed and validated, and offered, within a single laboratory. Thus, the FDA has not actively regulated most LDTs.”
Dan’s presentation will be part of Session 1: Oversight of LDTs: Patient and Clinical Considerations, and will make the case that a level playing field between IVD developers and Laboratories is the best approach for public health in the US. Today, if an IVD manufacturer wishes to bring a test to market, the regulatory requirements are much higher than those experienced by a laboratory introducing the same test.