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Sept. 20, 2013

FDA’s Unique Device Identifier Rule Years Delayed but a Welcome Step Forward for Medical Device Safety

Statement by Dr. Michael Carome, Director, Public Citizen’s Health Research Group

Public Citizen applauds today’s announcement by the Food and Drug Administration (FDA) that the agency at last has issued a final regulation requiring the implementation of a unique device identifier (UDI) system for medical devices. Public Citizen strongly advocated for a UDI system.

It’s regrettable that the agency took so many years to implement the rule, and it’s not perfect, but it’s a key step toward improving the safety of medical devices.

Presently, because of the lack of UDIs, alerts about medical device recalls do not always reach the appropriate health care providers and facilities and affected patients in a timely manner.

Among the significant benefits of the new UDI system, once implemented by the medical device industry, will be enhanced tracking and analysis of adverse events related to medical devices and more efficient, effective and complete implementation of medical device recalls.

The problems caused by the lack of UDI on medical devices have been well known for years, and finally the FDA is catching up to the problems under Congress’ orders.

Unfortunately, the full benefits of the new rule will not be seen for several more years because the deadline for having UDIs on many high- and moderate-risk devices will be in two to three years. A decade to implement such a commonsense system to improve patient safety is too long.

Congress first passed a law requiring the FDA to develop regulations for a UDI system when it renewed the agency’s medical device user fee program in 2007. However, because that law failed to provide a deadline for action, the agency was able to drag its feet without being held accountable. The White House’s Office of Information and Regulatory Affairs reviewed the proposed rule for an entire year, despite an executive order limiting review to 120 days. In 2012, Congress passed a law that specified a deadline for implementation of the UDI regulations. More prompt action by the FDA likely would have prevented numerous deaths and injuries related to unsafe medical devices.

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