An Insider’s Perspective on FDA’s UDI Strategy

By Daniel R. Matlis

To stay abreast of developments on FDA’s Unique Device Identification rule (UDI) and gain a deeper understanding of its impact on the Med-Tech Industry, patients and regulators, I have been speaking with Jay Crowley, Senior Advisor for Patient Safety, in the FDA’s Center for Devices and Radiological Health.  Mr. Crowley has responsibility for implementing the Unique Device Identification requirements.

The FDA recently issued the “Unique Device Identification System” rule for comment. UDI will require the application of “serial numbers” to most medical devices. In 2007, Congress passed legislation directing the FDA to develop regulations establishing a unique device identification system for medical devices. This set in motion a plan calling for “optimizing meaningful data collection and analysis.”

In this article, we discuss how UDI will allow FDA to optimize meaningful data collection and analysis to enable an integrated approach to Medical Device regulation.

Q. How will UDI impact the way FDA manages Medical Device information in the future?

A. UDI is integral to the future state that the agency is working towards. UDI is going to fundamentally change the way CDRH manages information about Medical Devices.  It will change the way that systems communicate with one another and the kinds of information that we collect in different systems.

Q. Will UDI drive changes to regulation, systems and processes at the Agency?

A. There’s a lot of work going on internally as well as with external organizations trying to understand the implications of UDI:   What other systems do we need to change?  What other regulations do we need to change – such as registration or listing, pre-market, or post market surveillance and product recalls?  We are actively looking to identify and understand the impact of UDI.

Q. How does the UDI program tie into FDA-wide initiatives and systems such as Sentinel?

A. The FDA team working on Sentinel has been intricately involved with UDI because without UDI we don’t have Sentinel for devices, it doesn’t exist.  So, they are anxiously waiting the implementation of UDI.  In addition, UDI can drive registries to tie all this information together and enable us to leverage the UDI database beyond the initial static Master Data perspective. We want to be able to integrate data from various sources, to evaluate whether  a particular product contains ingredient “X” or  ascertain some critical dimension.  We can then conduct research projects for Medical Devices and utilize analytics from information systems including Sentinel or Sentinel-like systems. Knowing that we are not going to have all of the necessary pieces of information prospectively, we have designed the system to allow us to add data to the UDI database in the future to answer public health questions.

Q. To support these efforts, do you plan to Integrate UDI with other FDA systems?

A. Our goal is to integrate our adverse event reporting so that someday in the future a reporter would be able to scan a UDI on the product label as they are reporting an event.   The event would automatically transfer relevant data to the electronic health record where that device’s UDI information would be stored.  In turn that ID would be transmitted from the device itself to a report and that report would then be transmitted to the FDA.

Q. What is the vision for this integrated approach?

A. In the ideal world, the vision would be that once FDA receives product information it would be bounced against our internal systems, like the recall databases or adverse event or pre-market, and we would be able to analyze all of that product’s information.

I look forward to future discussions with Jay Crowley and hope to provide additional insight based on our interactions.

It is worth noting FDA is seeking comment on this proposal until the end of October.

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