Guidance for Industry and for FDA Reviewers: Guidance on Section 216 of the Food and Drug Administration Modernization Act of 1997; Availability

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The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled "Guidance for Industry and for FDA Reviewers: Guidance on Section 216 of the Food and Drug Administration Modernization Act of 1997." This document provides guidance for industry on FDA's interpretation of the FDA Modernization Act of 1997 (FDAMA). The document describes how the Center for Devices and Radiological Health (CDRH) will apply the new provision and explains why FDA, through CDRH, has adopted this approach.