US: New FDA rule on use of symbols in medical device labeling

The final rule explicitly permits the use of symbols in medical device labeling without adjacent explanatory text if certain requirements are met. The medical device industry has requested the ability to use stand-alone symbols on domestic device labeling, consistent with their current use on devices manufactured for European and other foreign markets.
The final rule seeks to harmonize the U.S. device labeling requirements for symbols with international regulatory requirements, such as the European Medical Device Directive, and global adoption of standards IEC 60417 and ISO 7000-DB that govern the use of device symbols in numerous foreign markets (Federal Register, 15 June 2016).
Click here for Final Rule 81 FR 38911.
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If you have any questions about this subject, please contact us: info@nvc.nl, +31-(0)182-512411. This item is also included in our monthly overview, the NVC Members-only Update.