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@Regulatory: October 2013

FDA publishes the new UDI regulations – Will you be ready?


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On September 24, 2013, the United States Food and Drug Administration (FDA) published its much anticipated final regulation detailing requirements for medical devices and in-vitro diagnostic products to incorporate unique device identification (UDI) which enables these products to be tracked throughout the distribution chain to the ultimate end user. The main objective of the regulation is to help improve the quality of patient care in the United States by reducing the likelihood of medical errors in the healthcare system with the availability of improved data on device sourcing and distribution, device use, patient records including electronic health records (EHRs), disposition and adverse event investigation. Timing is crucial as the risk based approach taken by the FDA does not provide manufacturers much time to embed these new requirements into the R&D, manufacturing and distribution processes. For Class III (i.e., high risk devices), UDI technology and systems must be fully operational by September 24, 2014. In the case of manufacturers of only Class I or II devices, they have more time (up to 2018). In this edition of @Regulatory, potential recommendations for analyzing the current ruling and what it may mean to your organization are provided, such as creating a gap analysis and developing a prioritized implementation plan.

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