FDA发布最终规则：《符号在医疗器械标记中的使用》

John

6月15日，美国FDA发布了一篇题为《符号在医疗器械标记中的使用》的最终规则，允许在医疗器械标记中使用独立符号而无需在旁进行文字说明。该最终规则旨在协调美国和国际监管机构在器械标记符号使用方面对标记的要求。



该规则对医疗器械和某些生物制品的标记规定进行了修改，明确表示允许在标记（包括标签）上用图形传达信息（符号），而无需在旁进行文字说明（“独立符号”）。当一个符号被确定为由国家或国际标准开发组织（SDO）开发的标准的一部分时，该符号可作为一个独立符号使用（以下称为“标准化符号”），而且当医疗器械的标记包含符号术语表时，该标准化符号经授权可作为标准的一部分在标签上独立使用。

FDA还发表一篇新增认可标准的公告。该公告对FDA目前所认可的含有独立符号的标准的清单进行了修改，扩展了对6份标准的认可，并且新增认可了3份含有更多独立符号的共识标准。



英语原文



FDA issues Final Rule: Use of Symbols in Labeling

Today the Food and Drug Administration (FDA) issued a final rule “Use of Symbols in Labeling” allowing the use of stand-alone symbols in medical device labeling, without adjacent explanatory text. The final rule seeks to harmonize the labeling requirements of U.S. and international regulatory bodies with respect to the use of symbols in device labeling.

This final rule is revising the medical device and certain biological product labeling regulations by explicitly allowing graphical representation of information (symbols) in labeling (including labels) without adjacent explanatory text (“stand-alone symbols”). A stand-alone symbol can be used if the symbol has been established as part of a standard developed by a national or international standards development organization (SDO) (referred to as a “standardized symbol”) and such standardized symbol is authorized for stand-alone use in labeling as part of a standard when a symbols glossary is included in the labeling for the medical device.

The FDA also published a new standards-recognition notice that modifies the Agency’s current list of recognized standards containing stand-alone symbols to extend the recognition of six standards and to recognize three new consensus standards containing many more stand-alone symbols.


来源：Federal Registry     翻译整理：奥咨达