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FDA Issues UDI Proposed Rule: Roll-Out Expected in 2014
The Office of Management and Budget has approved the FDA’s long-awaited universal device identifier (UDI) proposed rule, clearing it for release by the FDA. The FDA says the rule, once implemented, will provide the cornerstone for a modern postmarket device surveillance program. First proposed in the FDA Amendments Act of 2007, each UDI will include a device identifier, which encodes the device model, as well as a production identifier, which includes the device’s batch or lot number and expiration date, if any.
Devices & Diagnostics Letter |
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