FDA has decided to delay the enforcement of unique device identification (UDI) requirements on Class I and unclassified products by two years.
In guidance issued this week, the agency said the identification of “additional policy and technical issues” as well as the impact of the COVID-19 pandemic persuaded it to hold off on enforcing the regulations until September 2022.
The delay means the requirements are set to come into force four years later than originally planned. FDA previously delayed enforcement by two years in 2018 in response to policy and technical issues.
FDA published a final rule on UDI in 2013 which set out how the agency planned to standardize device identification to support its postmarket surveillance activities. To give the industry “adequate time to build and test the systems and infrastructure required,” FDA established a staggered series of compliance dates based on the medical device risk classification system.
The final rule established September 24, 2018 as the compliance date for most Class I and unclassified medical devices. However, FDA dropped that target early in 2018 after identifying “complex policy and technical issues that require resolution to help ensure that UDI data are high quality and are available in standardized ways.” The delay pushed back the compliance date by two years.
Now, with the revised compliance date less than three months away, FDA has granted manufacturers of Class I and unclassified devices a further reprieve. The agency plans to begin enforcing the regulations in September 2022.
In explaining the delay, FDA said it has identified more policy and technical issues since it proposed the previous compliance date in 2018. The agency also continues to receive “many inquiries” related to the issues and sees value in focusing its attention on resolving problems related to the implementation of UDI for higher-risk devices.
Those aspects of the new guidance's explanation echo comments FDA made to explain the earlier delay. The key difference this time around is that the situation is complicated by the COVID-19 pandemic and the role the medtech industry is playing in responding to the outbreak.
“For those labelers that have not already implemented UDI requirements for Class I and unclassified devices, preparing to implement UDI requirements while addressing the challenges related to Coronavirus Disease 2019 could be very difficult and could divert resources from COVID-19 response efforts,” FDA wrote.
Such factors led the agency to delay enforcement of standard date formatting, UDI labeling and submissions to the Global Unique Device Identification Database for Class I and unclassified devices by two years. FDA will not enforce the requirements before September 24, 2022, regardless of when a device was made and labeled.
The agency also changed the deadline for compliance with the additional direct marking requirement that applies to reusable and reprocessed devices. Producers of Class I and unclassified devices subject to the requirement also have until September 2022 to comply.