Update on FDA Class I UDI
On July 1, 2020 the U.S. 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. Furthermore, 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, loss of trained staff and cost of restarting this activity by completing in-progress UDI labeling updates and submissions. Continuing your UDI plan is expected to be more productive and efficient than placing your process on hold and then reviving it later.
Organizations selling medical devices to regions outside the U.S., 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 U.S. UDI early due to the static nature of U.S. UDI requirements and availability of the GUDID for submissions. Global organizations complying with U.S. UDI early will benefit from flattening the UDI workload and applying lessons learned from the well-defined U.S. 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 U.S. 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. Reed Tech is here to assist you in complying with the U.S., EU, China, South Korea and other regional UDI requirements. Email us at: MedDevice@ReedTech.com or visit us at www.ReedTech.com.
Note: This recording was made prior to the July 1 FDA announcement. Exceptions and scenarios described still apply.