Global Unique Device Identification Database (GUDID) Data Submission and Management Requirements
This guidance provides detailed information for device labelers on submitting data to the Global Unique Device Identification Database (GUDID). It covers GUDID account management, device identifier (DI) record submission requirements, package information handling, and data retrieval options. The guidance applies to medical devices that require UDI labeling under 21 CFR 801.20.
What You Need to Know? 👇
What is the Global Unique Device Identification Database (GUDID) and who needs to submit data to it?
GUDID is FDA’s repository for device identification information containing Device Identifiers (DIs) and associated attributes. Medical device labelers must submit DI records to GUDID before introducing devices into commercial distribution, with records published within 15 calendar days of initial distribution.
How do I establish a GUDID account and what user roles are available?
To establish a GUDID account, you need a DUNS number and must identify a Regulatory Contact, Coordinator(s), and Labeler Data Entry (LDE) users. Submit your request through FDA’s UDI website. The account enables both web interface and HL7 SPL submission options.
What are the three DI record states in GUDID and their requirements?
The three states are: Draft (web interface only, can be saved for 180 days), Unpublished (passed business rules but publish date is future), and Published (available for public search). Only Published records fulfill GUDID submission requirements under 21 CFR 830.330.
What is the Grace Period for editing Published DI records?
The Grace Period is 7 calendar days starting the day after a DI record is published. During this period, all attributes except Publish Date can be edited. After the Grace Period, editing is limited and New DI trigger attributes cannot be modified.
How should package information be handled in GUDID submissions?
The Primary DI identifies the base package (lowest level with full UDI). Package configurations inherit base package attributes and include Package DI, Quantity per Package, Contains DI Package, and Package Type. Each package level requires its own DI unless it’s a shipping container.
What GMDN requirements apply to GUDID submissions and how do I obtain codes?
Each DI record requires at least one active GMDN Term Code. Since April 2019, GMDN Agency offers free basic membership for accessing codes. FDA PT codes are being removed from GUDID. Labelers must monitor GMDN terms for changes and update obsolete codes within 10 business days.
What You Need to Do 👇
Recommended Actions
- Establish GUDID account and determine submission method (Web Interface or HL7 SPL)
- Ensure proper DUNS numbers are obtained and verified for organization and labelers
- Identify and assign appropriate personnel roles:
- Regulatory Contact
- GUDID Coordinator(s)
- Labeler Data Entry users
- Develop SOPs for:
- Data quality management
- DI record submission process
- Record maintenance and updates
- Data governance if using multiple submission methods
- Obtain GMDN membership and identify appropriate GMDN terms for devices
- Implement system to track and manage:
- DI record states (Draft, Unpublished, Published)
- Grace period editing windows
- Package configuration information
- Commercial distribution dates
- Establish process for maintaining records according to 21 CFR Part 11 requirements
- Create system for monitoring and updating GMDN terms throughout device lifecycle
- Set up procedure for handling device discontinuation and associated GUDID updates
- If using third-party submitters, establish oversight mechanisms to ensure data accuracy and compliance
Key Considerations
Software
- Stand-alone software version number may be represented as Lot or Batch number production identifier
- Two submission options available:
- Web Interface for manual entry (low volume)
- HL7 SPL XML file submission via FDA ESG (high volume)
Cybersecurity
- Secure submission required through FDA Electronic Submissions Gateway (ESG) for HL7 SPL submissions
- Digital certificates needed for authentication of submissions through ESG
Labelling
- UDI must appear on device label and packages unless excepted
- Device identification data in GUDID should match information on device label
- For attributes appearing in medical device labeling, values submitted to GUDID should be consistent with labeling
Other considerations
- GUDID account required for submissions
- DI records must be submitted prior to device commercial distribution
- Published DI records must be maintained and updated throughout device lifecycle
- Records must be retained according to 21 CFR 830.360
- Third-party submissions allowed but labeler remains responsible for data accuracy
- Grace period of 7 calendar days after publication for unrestricted editing
- GMDN codes required for device categorization
- Package configuration information must be provided for all packaging levels
Relevant Guidances 🔗
- Electronic Records and Electronic Signatures - Scope and Application
- Unique Device Identifier (UDI) Form and Content Requirements
- Unique Device Identification Requirements for Convenience Kits
- Direct Marking of Devices with Unique Device Identification (UDI) Requirements for Reusable Medical Devices
- Unique Device Identification Policy for Class I and Unclassified Devices: Compliance Dates and Requirements
- Unique Device Identification System: Implementation and Compliance Requirements
Related references and norms 📂
- HL7: Standards for interoperability and healthcare data exchange
- 21 CFR Part 11: Electronic Records; Electronic Signatures
- 21 CFR 830: Unique Device Identification
- 21 CFR 801: Labeling