FDA Releases Final Rule on Unique Device Identifier

The Food and Drug Administration has released its final rule requiring most medical devices distributed in the United States to include a unique device identifier, according to a report from Premier Safety Institute.

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The rule is designed to improve the quality of information in medical devices after full implementation. Devices will be easier to identify in the case of adverse events and help healthcare providers and industry move more quickly to obtain information about the devices and manage recall more effectively.

Research has shown UDI can save as much as $16 billion annually, according to the report, by automating currently manual processes and improving efficiencies.

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