The jury is still out: FDA’s Unique Device Identification (UDI) System

While other government regulations like ICD-10 and Meaningful Use get all the headlines, as well as all of the positive and negative attention, the FDA's Unique Device Identification (UDI) System seems to be waiting in limbo like a defendant waiting for the jury to come back with it verdict. 

We decided to reach out to Spencer Nam, Senior Research Fellow, Health Care, Clayton Christensen Institute to ask him to share his thoughts about UDI and its future.

Jason Free: What are your thoughts on how the FDA's UDI project is impacting the medical device industry? Do you believe it is on the right track? If not, what adjustments need to be made?

Spencer Nam: Although it is a bit early to tell exactly how the UDI project is impacting the medical device industry, certainly the manufacturers, particularly those manufacturing Class III devices, must be feeling some urgency to address the issue, as the date of the first set of compliances has already passed (September 24, 2014). Based on some of the surveys done by various consulting and independent research institutions, I estimate that only about 30-40 percent of all Class III device manufacturers have met the first compliance date, and the rest of the manufacturers have asked for a one-year extension. I expect a similar compliance rate will apply for the second compliance date (September 24, 2015).

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Clayton Christensen Institute, interoperability, medical devices, UDI, Unique Device Identification System


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