US Food and Drug Administration regulatory oversight of laboratory-developed tests: Commentary on the draft guidance

Abstract

In 1976, Congress introduced the Medical Device Amendments to regulate medical devices intended for use in humans. The definition of "device" encompasses diagnostic devices manufactured by manufacturers as well as laboratory-developed tests (LDTs). To ensure that LDTs are safe and effective, on October 3, 2014, the US Food and Drug Administration issued a draft document outlining a plan to enforce its authority. A second draft document outlines the laboratory requirements for reporting their LDTs and adverse events related to testing.