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Home » Adverse Events in Other Countries Must Be Reported as MDRs in US
Adverse Events in Other Countries Must Be Reported as MDRs in US
December 14, 2009
Companies must report adverse events involving their devices that occur in other countries to the U.S. Food and Drug Administration (FDA) if the devices
are marketed in the U.S., according to a warning letter the agency sent to Sorin Biomedica.
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