Later this month the FDA will host a gathering of medical device and healthcare industry stakeholders for a discussion of the agency’s unique device identifier program for tracking and monitoring medical technology.
The federal watchdog agency is asking device makers, group purchasing organizations, healthcare distributors and other healthcare industry professionals to register for the 2-day conference, during which provide guidance on the program and how to comply with new rules for medical device labeling.
Earlier this summer the FDA issued a proposed rule on its long-awaiting UDI program, which 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.
This month’s conference aims to provide updates on the status of the regulation and help develop plans for implementation before the end of the commenting period for the UDI proposed rule, which closes November 7.
The system has been a long time coming. 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.
The federal watchdog agency granted a 120-day comment period to gather suggestions on the UDI proposal, after which it must issue a final rule within 6 months, meaning the FDA has until April 2013 to define the program.