National Medical Device Postmarket Surveillance Plan
FDA believes that national and international device registries in selected product areas and electronic health information (EHI) containing unique device identifiers (UDI) should serve as the foundation of our National Medical Device Postmarket Surveillance System. The system could be linked to longitudinal data, such as administrative and claims data, and would employ novel methods for evidence generation, synthesis and appraisal, modernized adverse event reporting and analysis, and would complement existing tools such as Medical Device Reporting (MDR), an enhanced surveillance network of approximately 280 hospitals (Medical Product Safety Network – MedSun), studies ordered by the FDA for selected devices (Post-Approval Studies and Postmarket Surveillance Studies), FDA research using other data sources (FDA Discretionary Studies), and other tools such as device tracking.
This was presented to the FDA’s Science Board on February 4, 2014.
National and International Device Registries and EHI Containing UDI – the Foundation of the Nation’s Medical Device Postmarket Surveillance System
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Sources: FDA/CDRH; Information from FDA Online/Seminar
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