Posted on July 7, 2010 by Debra A. McCurdy

FDA Guidance on Frequently-Asked Questions for In Vitro Diagnostic Studies

This post was written by Paul Sheives.

FDA issued a guidance document entitled “In Vitro Diagnostic (IVD) Device Studies -Frequently Asked Questions,” which is intended to help manufacturers and investigators regarding the development of IVD devices and IVD studies.  The guidance includes information on general regulatory issues, investigational studies, human subject protection, and data considerations. 

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