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FDA to Implement Unique Device ID Standards for Medical Systems

1 min read

FDA logoThe U.S. Food and Drug Administration says it is close to implementing a planned unique device identification system that will work to keep track of all medical equipment used in the country.

The agency consulted with stakeholders in adding a final rule to the framework that seeks to improve adverse event reporting for faster product recall, the FDA said Friday.

Through the system, the FDA also aims to simplify device use encoding into electronic health records and address potential counterfeiting issues.

Under the UDI system, the manufacturer attaches a unique device identifier number to all versions of its machines and other medical devices.

This ID number, which includes the lot or batch number, and the manufacturing and expiration dates, will then be uploaded on a searchable public database.

According to the agency, the project will be implemented in stages and the first phase will require Class III high-risk medical devices to carry identifiers within 12 months.

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