Berkley Life Sciences and Wilson Elser would like to invite you to a live webinar titled, "The FDA’s New Regulatory Scheme for Laboratory Developed Tests (LDT)". The FDA began regulating medical devices under the Medical Device Amendments of 1976. Because LDTs were simple tests typically designed for local labs and used for rare conditions, they were not included within this regulation.
Times have changed and LDTs have now become more complex and are frequently used to diagnose common but serious medical conditions. The FDA, generally, has not reviewed these tests to see if they are accurate, reliable or provide meaningful results. The FDA is now proposing a more comprehensive oversight framework for LDTs.