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UDI Exceptions, Exemptions and Extensions


UDI Exceptions, Exemptions and Extensions

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As the September 24 deadline approaches, a growing number of Class II labelers have been asking whether their devices might be somehow exempt from UDI requirements, or if at the FDA might grant them an extension. Unfortunately, while certain devices are exempt from UDI and the FDA has allowed extensions in rare situations, for most […]

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 […]

UDI in Europe and EUDAMED

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In 2013, the European Commission recommended working toward a harmonized European standard for a unique device identification (UDI) system for medical devices. Since then, regulators and industry have been working toward a final directive on the system to provide identification and traceability of medical devices across the 28 member countries of the European Union. That […]

50 Days Before I/LS/LS UDI Compliance Date

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Although the FDA recently extended the compliance date for the submission of Implantable, Life-Supporting and Life-Sustaining device UDI records by one month to October 24, 2015, that leaves just fifty days for affected labelers to finish the process. Just last week, we were contacted by an employee of a I/LS/LS device company whose UDI compliance program […]

FDA UDI System Status Update: Full Functionality Restored

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The FDA announced today that it has restored full functionality for the GUDID. This means that the Pre-production and Production environments of the FDA Web Interface are once again available for use.