The Food and Drug Administration will hold a free public workshop in September covering the adoption, implementation and use of a unique device identifier for medical devices, and how the identifier affects other systems, such as registries and databases within electronic health records systems.
A proposed rule to establish the device identifiers is under Office of Management and Budget review, which is one of the last steps before publication. Under the rule, the identifier will identify a device through distribution and use, and may include the lot or serial number. The identifier is mandated under the Food and Drug Administration Amendments Act of 2007.
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