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FDA IN VITRO DIAGNOSTIC CLINICAL TRIAL GUIDANCE

This article was originally published in The Gray Sheet

Executive Summary

FDA IN VITRO DIAGNOSTIC CLINICAL TRIAL GUIDANCE will probably be developed separately from the agency's general guidance document on device clinical trials, Richard Chiacchierini, director of the device center's Division of Biometric Sciences, said at a Jan. 24 session of the BioEast conference in Washington, D.C. Because of the unique characteristics of IVDs, the FDAer explained, "we are probably going to have to either devote an entire section to diagnostic devices in the guidance or create a new guidance document for diagnostic devices."
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