Life Sciences Blog

FDA Class I Medical Device UDI Due Sept 2022

by | Aug 30, 2021 | Life Sciences, Unique Device Identification | 0 comments

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.

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The most recent draft guidance from FDA concerning Class I devices may allow for exemptions for many products.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 may require compliance.

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 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.

Reed Tech is here to assist you in complying with the US, EU, China, South Korea and other regional UDI requirements. Email us at: [email protected] or visit us at www.ReedTech.com/UDI.

Questions? We are here to help. Visit our Knowledge Center or Contact Us. 

Reed Tech Life SciencesJoin us for our OTC drug product monograph webinar series!

Register here for the next webinar in an ongoing series of OTC-focused webinars featuring Reed Tech subject-matter experts and some of our industry friends and colleagues.

Get your limited time trial!

Sign up for a free limited trial of Navigator™ for Medical Devices