Food and Drug Administration (FDA)'s impact on laboratory performance: FDA's perspective
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چکیده
منابع مشابه
Food and Drug Administration (FDA)'s impact on laboratory performance: FDA's perspective.
The Division of Clinical Laboratory Devices is responsible for the premarket review of in vitro diagnostic devices (laboratory tests). We currently process >1000 diverse applications per year. New versions of old devices are handled as premarket notifications, so-called 510(k) submissions. The review objective is to establish that the new product is "substantially equivalent" to its predicate. ...
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ژورنال
عنوان ژورنال: Clinical Chemistry
سال: 1996
ISSN: 0009-9147,1530-8561
DOI: 10.1093/clinchem/42.5.786