The Department of Health and Human Services in its semi-regulatory agenda recently noted the Food and Drug Administration expects in September to publish a proposed rule to establish unique identifiers for medical devices.
Now, that rule has been transmitted to the Office of Management and Budget for 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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