FDA Formally Unveils LDT Draft Guidances Detailing Notification, Reporting Requirements

FDA Formally Unveils LDT Draft Guidances Detailing Notification, Reporting Requirements-insidehealthpolicy: FDA Tuesday (Sept. 30) released two draft guidance documents outlining how it plans to oversee laboratory developed tests, and the documents -- once finalized -- will set in motion notification, approval and reporting requirements for laboratories. The new documents delve into differing requirements for how laboratories would have to report adverse events when they are considered a facility using and manufacturing the test.