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Novation submits comments to FDA in support of UDI system for medical devices

Novation has submitted comments to the US Food and Drug Administration (FDA) in support of Unique Device Identification (UDI) system for medical devices.

The company believes that the proposed UDI rule, designed to overcome the substantial challenges with medical device and device package identification, will improve the safety of medical devices and will show a positive impact on the healthcare industry.

Novation general counsel, ethics and compliance officer and senior vice president Jill Witter said the use of a unique device identifier, similar to the FDA’s National Drug Code System, will help to substantially improve the accuracy of medical device identification and improve overall patient safety through the reduction of medical errors, efficient device recalls and enhanced device adverse event reporting.

"All of these improvements will enable hospitals to focus on what they do best – providing quality patient care," Witter added.

"Novation has been a leader in pushing for a unique device identifier standard, and we will continue to partner with the FDA and the hospital members we serve to maximize the benefits of a UDI system."