Draft Guidance for Industry and FDA Staff; Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use; Availability

摘要

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled "Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use." This document provides guidance on the use of selected symbols in place of text to convey some of the information required for in vitro diagnostic devices (IVDs) intended for professional use by FDA's labeling requirements for IVDs. This draft guidance is not final nor is it in effect at this time.