FDA Provides New Modules On Unique Device Identification (UDI) Program

By Jof Enriquez,
Follow me on Twitter @jofenriq

The U.S. Food and Drug Administration (FDA) is offering five additional learning modules on the topic of the Unique Device Identification (UDI) system for medical device manufacturers seeking direction on how best to comply with UDI requirements.

The new modules can be accessed via CDRH Learn, FDA’s Center for Devices and Radiological Health (CDRH) web page for multimedia industry training and continuing education.

According to Emergo, the modules include:

• An overview of the FDA UDI system and regulations, data and label requirements and implementation schedules
• Preparing a Global Unique Device Identification Database (GUDID) account request and creation
• GUDID Device Identifier Record requirements and submission options
• GUDID HL7 SPL submission options, formats, and other requirements
• How to submit data to GUDID using appropriate submission options

In the UDI overview module, participants are introduced to the UDI program, including its rationale, the four steps of the UDI system, labeler requirements, compliance dates, and the benefits of adopting the UDI program.

The GUDID modules guide trainees through the account request process, preparing the necessary information to open an account and make successful data submissions, evaluating the GUDID data submission options, choosing the right one for the organization's specific needs, understanding how to use the FDA UDI Help Desk to request an account, and understanding how to properly ask the UDI Team about UDI requirements.

A related module lets participants review the components of UDI and GUDID, then delves deeper into the data elements in a device identifier (DI) record, how to manage the DI record through the life of a device so information stays updated, and offers best practices for better GUDID data.

There is a dedicated module for Health Level 7 Structured Product Labeling, or HL7 SPL submissions option to the GUDID. This module talks about the required testing before sending Production GUDID submissions, the FDA Electronic Submissions Gateway or ESG for the submissions, and provide some pointers on how to edit and manage DI records, and how to use third-party submitters.

According to the FDA, the UDI program will improve patient safety, modernize device postmarket surveillance, and facilitate medical device innovation. The agency has implemented a phased approach for medical device companies to comply with the UDI program. FDA's training and information modules aim to bring clarity and guidance as the implementation continues.