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 compliance deadline, we are aware of many healthcare organization who are demanding UDI adoption ahead of FDA’s compliance deadlines. Please consider this as you continue planning your UDI implementation strategy.
It is also critical to understand that this document does NOT change the compliance dates for these devices, which would require re-publishing the regulation for notice and comment. Rather, it states that “…FDA does not intend to enforce the standard date formatting, labeling, and GUDID data submission requirements … for these devices before September 24, 2020.” This does not mean that they cannot enforce these requirements – but that, in general, they do not intend to enforce the UDI requirements. And, without any further explanation – but in keeping with the rule’s original implementation construct – the guidance also states that FDA “…does not intend to enforce direct mark requirements …for these devices before September 24, 2022” (in keeping with the additional 2 year compliance timeline beyond the label requirements granted for the additional direct marking requirement).
Moreover, because of the way the UDI regulation is constructed, it is worth mentioning how this “enforcement discretion” affects the existing inventory exception. The original exception allowed that finished class I and unclassified devices, manufactured and labeled prior to September 24, 2018, were further exempt from the UDI requirements for an additional three years after the original (published) compliance date (September 24, 2018). That is – a finished device, placed into inventory by September 24, 2018 could continue to be distributed without being UDI compliant until September 24, 2021. This guidance document does not change those dates – the existing inventory exception does NOT now start in 2020 and extend to 2023 – but rather still starts on September 24, 2018 and ends September 24, 2021. Therefore, any class I or unclassified device manufactured after September 24, 2018 (this year) will need to be UDI compliant – if not already in commercial distribution – by September 24, 2020. This needs to be managed very carefully.
Finally, it is interesting to note that FDA has decided to take this approach despite the UDI regulation’s very clear, fully vetted and established compliance timelines. In fact, FDA received more comments about the compliance dates than any other part of the proposed regulation. FDA summarized their response to these many comments in this way:
“FDA received many comments … suggesting changes to the compliance dates … Roughly one-third of the comments that expressed a specific view recommended a more rapid implementation of the rule’s requirements in order for the rule’s benefits and goals to be more rapidly achieved… Roughly two-thirds recommended FDA allow more time in order to better manage the tasks required to meet the rule’s requirements and to spread the costs of implementation over a longer period of time… However, FDA does not agree with any comment that seeks broad changes to the proposed timeframes for implementation of UDI … Overall, we [FDA] believe the schedule laid out in the amended proposed rule … strikes a realistic balance between desires to quickly see benefits from the UDI system and the challenges that must be met … to meet the new regulatory requirements and for effective and efficient administration of UDI processes.”
It is also interesting that FDA published this guidance without opportunity for comment because “…the Agency has determined that prior public participation is not feasible or appropriate…” I think that there are many of us who are driving UDI adoption to realize UDI’s many benefits who would have liked an opportunity to comment on this (unnecessary?) delay…
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About the Author
Jay Crowley is the Vice President of the UDI Services and Solutions at USDM Life Sciences. Jay was most recently 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 FDA’s Unique Device Identification system.
About USDM Life Sciences
USDM Life Sciences is a global life science and healthcare services company, providing strategy and compliant technology solutions to regulated industries. If you work in Life Sciences or Healthcare, partnering with USDM Life Sciences makes it easy to accelerate innovation and maximize productivity. USDM Life Sciences only focuses on regulated industries and has built trusted partnerships with the most innovative technology companies in the world, and boast a staff of industry leading experts in the areas of technology and compliance.