Key Insights Into the FDA’s Updated GUDID Guidance
On December 17th, 2024, the Food and Drug Administration (FDA) issued an updated final guidance on submitting data to the Global Unique Device Identification Database (GUDID). This document replaces the guidance originally published in June 2014, offering medical device labelers insights into the FDA’s current expectations for GUDID submissions, updates on Global Medical Device Nomenclature (GMDN) field changes, and minor revisions from the original guidance. Explore the key takeaways from the guidance below.
Removal of FDA Preferred Terms (PT) Codes
The FDA plans to remove FDA Preferred Term (PT) Codes from GUDID, as the GMDN Agency’s 2019 update allows free access to GMDN Terms. GUDID users are encouraged to immediately adopt GMDN Codes in preparation for this transition. Once implemented, this change will be reflected in the GUDID Data Elements Reference Table.
Comprehensive Labeling Requirements Reinforced in the UDI Rule
The UDI Rule, established to enhance device traceability and identification, is not new, but the guidance document reaffirms its requirements and provides clarity on compliance. The rule mandates that all medical device labels and packaging must include a UDI unless explicitly exempt. This ensures accurate identification of devices across distribution, usage, and various packaging configurations (21 CFR 801.20(a)(2)).
For devices sold in individual packages, the UDI must be clearly labeled on each package, as well as on the box containing those packages and the carton enclosing the box. These requirements also extend to combination devices, convenience kits, in vitro diagnostic (IVD) products, devices derived from human cells or tissues (HCT/Ps), and standalone software. The guidance reinforces these established standards, highlighting their continued importance in ensuring regulatory compliance and effective device tracking.
Managing DI Records Across States and Packaging Levels
Device Identifier (DI) records are a fundamental component of the UDI, uniquely identifying the labeler and specific device version. DI records can exist in three states: Draft, Unpublished, and Published. Draft records expire after 180 days of inactivity, while unpublished records allow indefinite editing. Once published, DI records provide a 7-day grace period for full edits, after which only limited changes are permitted.
To ensure compliance and traceability, each device record must include a Primary DI to identify the lowest level of packaging containing a full UDI, referred to as the base package. Additional identifiers may include Secondary DIs, Unit of Use DIs for individual devices, Direct Marking DIs for permanently marked devices, and Package DIs for various packaging configurations.
Lifecycle and Quality Standards for DI Records
The FDA emphasizes a lifecycle management approach, making it the responsibility of labelers to maintain accurate and up-to-date DI records throughout the Total Product Lifecycle (TPLC). DI records must adhere to the GUDID Business Rules, which are designed to uphold data accuracy, consistency, and reliability. This ensures effective device tracking and supports regulatory compliance.
Submission Pathways for GUDID Data
The FDA provides two submission pathways for entering device information into the GUDID system:
- GUDID Web Application: Suitable for low-volume submitters, requiring manual data entry.
- HL7 SPL XML File Submission: Designed for high-volume submitters via the FDA’s Electronic Submission Gateway (ESG).
Upcoming Enhancements to GUDID
The FDA is enhancing the GUDID system to improve user experience and strengthen validation rules. These updates are based on user feedback, and the FDA will update the guidance document as enhancements are rolled out.
By addressing comprehensive labeling requirements, DI record management, submission pathways, and upcoming enhancements, the guidance underscores the importance of robust systems for ensuring regulatory compliance and effective device traceability.
Need Assistance?
Navigating the complexities of GUDID submissions and UDI compliance can be challenging—but Rook Quality Systems is here to help. Here’s how we can support your organization:
- Develop a Tailored GUDID Submission Strategy: Ensure your device data is accurate, complete, and aligned with FDA requirements.
- Maintain Data Integrity Across the Total Product Lifecycle (TPLC): Rely on us to keep your records current and compliant, from initial submission through updates.
- Implement Compliant Systems: Streamline your processes with systems designed to meet UDI and GUDID requirements.
- Leverage Expertise: Benefit from our team’s in-depth knowledge of UDI regulations and proven track record in helping clients achieve compliance.
Ready to streamline your compliance journey? Partner with Rook Quality Systems to meet your regulatory needs with confidence—so you can focus on driving innovation. Let’s make compliance seamless together. Reach out to us today!