Abstract

Laboratory developed tests (LDT) are usually referred to the diagnostic methods for the medical laboratory, which can only be used in the medical laboratory and can not be sold to other medical laboratories, hospitals and individuals. The paper shows the draft guideline of LDT issued by Food and Drug Administration (FDA) and the suggestions of clinical laboratory experts and relevant academic groups for different FDA monitoring models.(Chin J Lab Med, 2016, 39: 55-59) Key words: Clinical laboratory techniques; Quality control

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