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US Food and Drug Administration regulatory oversight of laboratory‐developed tests: Commentary on the draft guidance
Author(s) -
Sidawy Mary K.
Publication year - 2015
Publication title -
cancer cytopathology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.29
H-Index - 57
eISSN - 1934-6638
pISSN - 1934-662X
DOI - 10.1002/cncy.21566
Subject(s) - food and drug administration , medicine , administration (probate law) , regulatory authority , public administration , medical emergency , law , political science
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.