Guidance for Industry and Food and Drug Administration Staff; In Vitro Diagnostic Studies-Frequently Asked Questions; Availability

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The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled "In Vitro Diagnostic (IVD) Device Studies--Frequently Asked Questions." FDA is issuing this guidance to assist manufacturers in developing and conducting studies for IVD devices, particularly those exempt from most of the Investigational Device Exemption (IDE) regulations. The guidance explains data considerations that ultimately will affect the quality of the premarket submission. The draft of this guidance was issued October 25, 2007.