FDA's next-gen medtech surveillance bets heavily on unique device identifiers

April 24, 2013 by Arezu Sarvestani

The FDA envisions a modernized medical device postmarket surveillance system, in which the long-awaited Unique Device Identifier program plays a big role.

FDA with magnifying glass

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.

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The FDA's 2012 proposed UDI rule laid out a 5-year approach to implementing the program, focusing 1st on the highest-risk devices and exempting lower-risk products from some or all of the requirements. Congress initially approved the UDI program in 2006 to enable tracking of medical implants and to add medical devices to the Sentinel post-market surveillance program that currently monitors prescription drug safety.