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FDA UDI Enforcement: 4 Things to Consider


FDA UDI Enforcement: 4 Things to Consider

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While recently speaking with a regulatory manager who works at a medical device manufacturer with a large Class II product portfolio, I was surprised to hear that his organization was not concerned about meeting the FDA’s UDI requirements by the September 24 deadline. He confided he is personally worried about the potential consequences, but upper […]

UDI Submission Load Testing

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As I talk to medical device industry members about their plans for UDI, I continue to find many organizations that have not yet begun making their submissions to the GUDID. A lot of labelers have collected their data, modified their labels and taken the other steps necessary to meet the FDA’s UDI mandate but are […]

FDA Update on UDI Implementation

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On December 18, 2014, the U.S. Food & Drug Administration (FDA) released an Update on UDI Implementation for Registered Medical Device Establishments.