Update on FDA Class I UDI
On July 1, 2020 the US Food and Drug Administration (FDA) issued a Guidance document 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 labeling and GUDID data submission requirements for Class I and unclassified devices before September 24, 2022.
What does this mean for you?
The enforcement moratorium is set to expire on September 24, 2022, at which time UDI compliance becomes mandatory for 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.
Organizations selling medical devices to regions outside the US, such as EU, China and South Korea, face additional global UDI-type compliance mandates in 2022. Reed Tech recommends that organizations selling products globally comply with US UDI early due to the static nature of US UDI requirements and availability of the GUDID for submissions.
Global organizations complying with US 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.
How can we help?
Reed Tech can assist your organization in understanding the impact of US and global 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.