What are the requirements for Class I medical devices concerning unique device identification (UDI) data submission to US FDA GUDID?
Class I devices, and devices that have not been classified into class I, class II or class III that are required to be labeled with a UDI, must bear UDI as a permanent marking on the device itself if the device is one that is intended to be used more than once and intended to be reprocessed before each use. §801.45.
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.
Remember, the FDA is simply strengthening public health with standards that ensure safety, security, and reliability. The Global Unique Device Identification Database (GUDID, pronounced “Good ID”) will allow for a single database of all devices with unique device identifiers (UDIs) submitted to the FDA. The UDI system allows medical devices to be better labeled as what they are and what they are used for across the healthcare industry.
GUDID contains only the device identifier (DI) of the UDI, and typically represents the device model or version. This (DI) can be submitted by manual web interface or bulk xml file upload to GUDID, but the timeline to prepare and correctly submit is often underestimated. Before you submit anything, you’ll want to ensure you correctly follow the guidelines based on your medical device class.
In this session of Reed Tech Insights, review some critical reminders for Class I medical devices. Note this recording occurred prior to the shift in compliance from 2020 to 2022, however, the noted exceptions and scenarios are still applicable.
As you are navigating the guidance and completing UDI requirements, Reed Tech is available to help with SingleSource™ for Medical Devices. Expert Reed Tech staff work with your regulatory team to smoothly navigate each stage of UDI data submission – especially if you have limited staff resources to devote to UDI data compliance.
Contact us to learn more: MedDevice@ReedTech.com