Update on FDA Class I UDI as of July 22, 2022
Final guidance has been issued by the US Food and Drug Administration (FDA) for labelers of Class I medical devices.
In an effort to help the industry remain focused on high-quality Unique Device Identification (UDI) submissions and COVID-19 response efforts, the agency announced it does not intend to enforce standard date formatting, UDI GUDID data submission requirements for Class I and unclassified devices before December 8, 2022. (previous guidance was September 24, 2022. UDI labeling is still due September 24, 2022.)
In general, the UDI final rule requires device labelers (typically, the manufacturer) to:
- Include a unique device identifier (UDI), issued under an FDA-accredited issuing agency’s UDI system, on-device labels, device packages, and in some instances, directly on the device.
- Submit device information to the Global Unique Device Identification Database (GUDID).
The Final Guidance from FDA concerning Class I devices allows exemptions for many products. Exemptions include ‘Good Manufacturing Practice’ (GMP), if the product is carrying a UPC label currently, is 510(k)-exempt and sold exclusively to consumers over-the-counter. Other scenarios require compliance.
What does this mean for you?
The enforcement moratorium is set to expire on December 8, 2022, at which time UDI compliance becomes mandatory for some Class I medical devices. In light of this, labelers may now dedicate additional time to securing accurate and quality product data for compliance with the 2022 UDI mandate. The FDA’s GUDID is available today for submission of Class I product data, and organizations can use this information as a resource to meet customer requirements for structured product catalog data.
Your organization may have already generated momentum, management support and funding toward meeting the FDA’s UDI compliance requirements. Your team can avoid losing team focus and the costs of restarting this activity by completing in-progress UDI labeling updates and submissions.
How can we help?
Reed Tech can assist your organization in understanding the impact of US FDA and other global health authority UDI compliance requirements. Our UDI solution is uniquely positioned to provide you the training and support needed throughout the data collection, submission and maintenance process, saving you time and money along the way.
Global organizations complying with US FDA UDI early will benefit from flattening the UDI workload. Apply the lessons learned from the well-defined US UDI mandate. An established UDI process and proven data management system are valuable assets in meeting other regional health authority UDI regulations in 2022 and in the future.
Note: Video below was recorded from a recent webinar on Class I UDI submission requirements and exceptions. View the full webinar here.