Prospective IVD Trials: When Are They Necessary?

IVD developers sometimes find it surprising that it is not enough to demonstrate the analytic validity of a test - the ability of the test to determine whether what it is designed to detect is present or absent. IVD developers may expect existing scientific knowledge and a series of informed inferences to connect the dots [...]

Prospective IVD Trials: When Are They Necessary? 2018-08-14T21:12:52+00:00
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