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by Jay Crowley In FDA’s UDI System final rule, FDA made a number of changes to other regulations to leverage the use of UDI in those regulations. These are called the conforming amendments. Interestingly, we have found that the conforming amendments are a part of UDI implementation that many manufacturers (labelers) have not adequately considered, incorporated, or documented. All of the conforming amendments can be found in the final rule, but today I want to focus on one of the less discussed regulations – Part 821 on Medical Device Tracking Requirements. The tracking requirements have had a long and…
by Jay Crowley We are rapidly approaching the 5-year anniversary of the publication of the US Unique Device Identification (UDI) regulation – which itself was the culmination of nearly ten years of work by a large, dedicated group of us who believed in UDI’s ability to positively transform the entire medical device ecosystem.  At the same time, we also developed the Global Harmonization Task Force (GHTF) – and then International Medical Device Regulators Forum (IMDRF) – UDI Guidance Document in the hopes of fostering a globally harmonized approach to UDI.  And now we are seeing the next…
by Jay Crowley On January 12th, FDA published an immediately-in-effect (IIE) guidance document titled “Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices,” (available here). The guidance states that this period of “enforcement discretion” is necessary to allow FDA to “…focus its resources on addressing existing implementation challenges and optimizing the quality and utility of UDI data for higher-risk devices before focusing on UDI implementation issues for lower-risk devices.”  It is worth noting, however, that although we are not aware of any requests by class I device manufactures to FDA to extend the…
by Jay Crowley Join Jay at the MDR & IVDR EU Conference, December 4-6 in Orlando, Florida! On 5 April 2017, the European Medical Device (MDR) and In Vitro Diagnostic Medical Device (IVDR) Regulations were published in the Official Journal of the European Union – the last step in their long and arduous journey. The MDR applies from 26 May 2020 and the IVDR applies from 26 May 2022. These new regulations were developed because “… a fundamental revision of those Directives [on medical devices, active implantable medical devices, and in vitro diagnostic medical devices] is needed to establish…
by Jay Crowley We are excited to be at the Medtec Ireland conference in Galway this week. As an Irish descendant and a Guinness aficionado – I always enjoy my trips to the Emerald Isle. Ireland is home to many medical device manufacturers (8 of the world’s 10 largest medical device companies are located in Ireland – and 18 of the top 25 devices companies have a base in Ireland) and a good deal of sophisticated manufacturing of devices that are distributed globally. And of course, the big topic for EU countries (as well as those countries that leverage the…
by Jay Crowley Over the past 15 years, I have been fortunate enough to travel around the globe discussing and developing Unique Device Identification (UDI). I am always struck by how similar – and yet interestingly different – people, societies, and countries (as well as the regulation of medical devices) are around the world. Nowhere is this truer than in China. Though the people of China are similar in many ways, there is so much that is different. There are differences in the language (both written and spoken), the food, the culture, the politics, and the “eastern”…
by Jay Crowley As I mentioned in my last post, I believe our goal of a “globally harmonized” approach to UDI appears to be on a path to relative success. Though not our intent in developing the Global Harmonization Task Force (GHTF) and International Medical Device Regulators Forum (IMDRF) UDI guidance documents, the majority of the EU Medical Device Regulations (MDR)/In Vitro Diagnostic Regulations (IVDR) UDI System requirements are literally copied and pasted from the IMDRF guidance document (please send an email to usdm@usdm.com if you would like a copy of the comparison). More importantly, other regulators…
by Jay Crowley As I mentioned in my last post, we were focused not only on developing a US UDI System, but maybe more importantly on a globally harmonized approach to UDI. There were a number of reasons for this; the first, and hopefully obvious one, is that a global UDI would allow all to have visibility across the global supply chain and be better able to share data among regulators about the safe and effective use of devices and, for example, be able to identify problems more quickly or address recalls across borders. Moreover, the device…

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