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Under Medical Device Reporting (MDR) is a manufacturer responsible for notifying the FDA if the incident occurred overseas?

Medical Device Reporting (MDR) is the mechanism for the Food and Drug Administration to receive significant medical device adverse events from manufacturers, importers and user facilities, so they can be detected and corrected quickly. 

If the incident meets the criteria for a reportable event and if the same device is being sold in the US – you DO have to inform the FDA,.