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WHAT: Laboratory developed test (LDT) is in vitro diagnostic test designed, manufactured and used within a single laboratory

WHY: To measure or detect analytes in sample taken from a human body

WHO:  Individual labs. However, diagnostic devices not considered to to be LDTs if they are designed or manufactured completely, or partly, outside of the laboratory that offers and uses them.

HOW: FDA does not enforce premarket review as tests are relatively simple. However, FDA concern with some high-risk LDTs (e.g. cancer detection)  with unsubstantiated claims, erroneous results, data falsification. Discussion paper issued in Jan 2017

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