International News In Brief
This article was originally published in The Gray Sheet
Executive SummaryCongress passes U.S.-Korea Free Trade Agreement
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Canada issues final pre-market license guidance for makers of class II and IV devices. U.K. explains requirements for home-use diagnostics. More international news.
The European Commission releases a final regulation detailing requirements for device manufacturers who wish to provide instructions for use in electronic form. EC also offers guidance on the regulatory status of stand-alone medical software. More international news.