Tag: Postmarket Surveillance Plan

16
Feb

National Medical Device Postmarket Surveillance Plan

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,

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