Replacement Reagent and Instrument Family Policy for In Vitro Diagnostic Devices; Guidance for Industry and Food and Drug Administration Staff; Availability
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Issuing agencies
Abstract
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled "Replacement Reagent and Instrument Family Policy for In Vitro Diagnostic Devices." This guidance is intended to update and provide clarity on the replacement reagent and instrument family policy for manufacturers of in vitro diagnostic devices and FDA staff to promote consistent application of the concepts in this guidance. Specifically, it addresses a manufacturer's application of an assay that was previously cleared for use based on performance characteristics when used with a specified instrument to an additional instrument that was previously cleared, or that is a member of an instrument family from which another member has been previously cleared. This document supersedes the final guidance "Replacement Reagent and Instrument Family Policy" issued on December 11, 2003.
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