The FDA envisions a modernized medical device postmarket surveillance system, in which the long-awaited Unique Device Identifier program plays a big role.
The FDA laid out plans to revamp its postmarket surveillance of medical devices, and a large part of that has to do with finalizing and implementing a long-awaited Unique Device Identifier program to better track and monitor devices.
The federal watchdog agency aims this year to finalize a UDI rule, building on a proposal released in July 2012. The rule would require most medical devices to carry labels with unique codes and scannable barcodes that will allow healthcare providers, regulators and the public at large to track the devices and monitor safety.
The UDI system will include a publicly accessible global UDI database, incorporation of UDI into electronic health records, a pilot UDI demonstration in a multi-hospital information system and a think-tank report to inform full implementation, according to a new FDA report.