The proposed rule would provide medical device manufacturers with the option to use standardized international symbols (recognized by the FDA) to communicate information to end users. This option would allow manufacturers to substitute labels containing only written statements (text-only labels) with a label containing only symbols (symbol-only labels), granted that the symbols communicate the same information as the substituted written statements.

Regulatory Impact Analysis

Analysis of Economic Impacts: Use of Certain Symbols in Labeling: Proposed Rule (PDF - 515KB)

Federal Register: 78 FR 23508-23515, April 19, 2013

Docket: FDA-2013-N-0125