Zdrowie i gospodarka · 9/8/1999
Medical Devices; Draft Guidance on Labeling for Laboratory Tests; Availability
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled `` Draft Guidance on Labeling for Laboratory Tests.'' This draft guidance is not final nor is it in effect at this time. The draft guidance is intended to identify the information that should be provided to FDA for labeling the diagnostic performance of laboratory tests. FDA intends to recognize two major categories of endpoints for assessing diagnostic performance of new ``in vitro diagnostic'' assays.