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CDRH to Strengthen Postmarket Surveillance, Plans Proactive Electronic Data Analysis

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Building on the enhanced tracking abilities that will be created by implementation of unique device identifiers (UDI), the FDA plans to begin rolling out by year’s end an enhanced postmarket surveillance program for medical devices. The CDRH plan involves tying UDIs into electronic health records to better identify patients experiencing possible adverse events. Additionally, the center would establish international adverse event registries for certain types of devices so incident data could be analyzed across an entire category of devices.
Devices & Diagnostics Letter