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

Streszczenie

The Food and Drug Administration (FDA) is announcing the availability of the 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 from international standards already recognized by FDA 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.