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Jay Crowley’s UDI Compliance Progress Report

It is hard to believe that it has only been 2 years since I announced the publication of the UDI final rule on September 24, 2013 at the UDI Conference – it feels like a lifetime ago. So much has happened in the intervening 2 years – so many unexpected issues (accessories, labelers), so many complex device issues, so many UDIs. We all continue to learn and refine our understanding of UDI, how it can and should apply to a myriad of device types, and how the GUDID data should be populated and used.

It is interesting that this year marks the compliance data that we did not originally envision – but rather was legislatively mandated in FDASIA (2012). Though the premarket risk class of (most) devices is fairly obvious – determining whether a device is subject to this year’s compliance date (what we call the FDASIA devices – all class II and I implants and life-supporting/life-sustaining devices) is a bit more of a challenge. As always, we encourage you to check FDA’s website to determine whether your device, based on its product code, is subject to the UDI requirements this year.

And finally, the guidance document that FDA published on August 14, 2015 “Global Unique Device Identification Database (GUDID): Data Submission Compliance Date of September 24, 2015” has created some confusion. Due to a security vulnerability in GUDID, on August 7, 2015 FDA decided to take the system offline to develop and implement a patch. Though it came back on-line relatively quickly, due to the temporary unavailability of the GUDID system, FDA intends to exercise enforcement discretion to extend the September 24, 2015 GUDID submission compliance date to October 24, 2015. That is, ONLY the GUDID submission requirement is subject to this enforcement discretion – all of the other UDI requirements are still due September 24, 2015.

Jay Crowley is the Vice President of UDI Services and Solutions at USDM Life Sciences. Jay was Senior Advisor for Patient Safety in the Food and Drug Administration’s Center for Devices and Radiological Health. Jay developed the framework and authored key requirements for the FDA’s Unique Device Identification system.

USDM Life Sciences will help you assess, plan and execute the changes and enhancements necessary to meet UDI regulations. Our team of UDI experts will assess your products, the markets where they are sold and determine an implementation strategy for the changes that need to be made. USDM's assessment methodology is extensive and includes the labels and packaging, the management of identification changes to each product, the changes to PLM, ERP, EPCIS and packaging systems, changes to printing, vision inspection and warehouse/inventory management systems and interfaces to the GUDID.

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    I have had the great pleasure to work with Bob for 5 years in his position of VP of Quality at Fisher Packaging Services while I acted as Director of Quality services at a sister…
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