GUDID & UDI Setup Services for Medical Device Manufacturers
Are you preparing to market a medical device in the United States and need support with Unique Device Identification (UDI) and the FDA's Global Unique Device Identification Database (GUDID)? The GUDID & UDI Setup service from Cosmetic Compliance Nest helps medical device businesses organise device identification information, review applicable labelling requirements, and prepare relevant database data.
UDI and GUDID requirements play an important role in medical device identification and traceability. Depending on the device and applicable regulatory requirements, manufacturers and other responsible labelers may need to assign a UDI, include the required identifier on device labelling, and submit relevant device information to GUDID.
Our service provides structured support for reviewing device information, preparing applicable database fields, and understanding the steps involved in UDI and GUDID compliance for the US market.
What Are UDI and GUDID?
A Unique Device Identifier (UDI) is a device identification code used to identify a medical device. It generally consists of a Device Identifier (DI) and, where applicable, a Production Identifier (PI).
The Device Identifier identifies the specific device labeler and device version or model. The Production Identifier may include production-related information, such as a lot or batch number, serial number, expiration date, or manufacturing date, where applicable.
The Global Unique Device Identification Database (GUDID) is maintained by the US Food and Drug Administration (FDA). It contains the DI and key identifying information about medical devices subject to applicable requirements. GUDID does not store the actual production identifier values.
What Does Our GUDID & UDI Setup Service Cover?
- Initial Requirements Assessment: Review available device details to help determine the applicable UDI and GUDID requirements and identify potential exceptions or alternatives for further consideration.
- Device Identifier Guidance: Provide guidance on the DI and relevant issuing-agency considerations for the applicable device.
- GUDID Data Preparation: Help organise the device information required for relevant GUDID data fields, based on the device and agreed scope.
- Device Information Review: Review details such as the device name, model or catalogue number, labeler information, and other applicable identifying attributes.
- Packaging and Configuration Review: Help assess relevant device packaging levels and configurations where these affect the identification and database information requirements.
- UDI Labelling Guidance: Review applicable requirements for presenting UDI information in human-readable and machine-readable formats, subject to the device's regulatory requirements.
- GUDID Submission Preparation: Assist with organising data and preparing the information needed for database submission, within the agreed service scope.
- Data Consistency Review: Check the consistency of available device identification information against the documentation provided by the client.
- Record Maintenance Guidance: Explain relevant considerations for maintaining or updating applicable GUDID records when device information changes.
The precise scope depends on the device, the responsible labeler, the information available, account access, and the services agreed before work begins.
Who Should Consider This Service?
- Medical device manufacturers planning to enter the US market.
- Foreign manufacturers supplying medical devices to the United States.
- Device labelers responsible for applicable UDI and GUDID obligations.
- Businesses preparing device identification data for a new medical device.
- Companies reviewing existing UDI labels or GUDID records.
- Medical device businesses managing multiple models, packaging levels, or product configurations.
- Organisations seeking guidance on applicable FDA device identification requirements.
Our GUDID & UDI Setup Process
- Initial Assessment: Review your device type, available product information, manufacturer or labeler details, and intended US market activities.
- Requirements Review: Identify the relevant UDI and GUDID requirements for assessment, including potentially applicable exceptions or alternatives.
- Information Collection: Organise the device identification details and supporting information required for the agreed work.
- UDI and Labelling Review: Review applicable identifier and labelling information based on the available documentation and agreed scope.
- GUDID Data Preparation: Help prepare the applicable device information for database entry or submission.
- Quality and Consistency Check: Review the prepared information for inconsistencies or missing details that can be identified from the supplied records.
- Submission Support: Provide the agreed level of guidance or assistance with the GUDID submission process, subject to the required access and permissions.
- Final Review: Where included in the package, review the available submission status or published record details.
Benefits of Professional UDI and GUDID Support
- Better Data Organisation: Structure device identification information before preparing a database record.
- Improved Information Consistency: Identify potential discrepancies between supplied product information and prepared GUDID data.
- Clearer Regulatory Understanding: Develop a better understanding of applicable UDI, database, and labelling requirements.
- More Structured Preparation: Follow an organised process for collecting and reviewing relevant device information.
- Support for US Market Planning: Understand the device identification tasks that may form part of broader regulatory preparation.
- Record Maintenance Awareness: Understand the importance of reviewing and maintaining applicable device identification records when changes occur.
Documents and Information You May Need
Depending on your device and the agreed service scope, the following information may be requested:
- Device name and product description.
- Manufacturer and responsible labeler details.
- Model, catalogue, or reference numbers.
- Existing DI or UDI information, if already assigned.
- Details of device packaging levels and configurations.
- Applicable device classification and regulatory information.
- Product labels, artwork, or relevant packaging information.
- Information about lot or batch numbers, serial numbers, expiration dates, or other applicable production identifiers.
- Existing GUDID record details, where applicable.
- Relevant account access or authorisation needed for submission support, where agreed.
Not every item will be required for every device. The necessary information depends on the applicable regulatory requirements, device characteristics, and the agreed scope of work.
Understanding UDI and GUDID Requirements
UDI and GUDID are related but serve different purposes. UDI concerns the identification of a medical device and its applicable labelling requirements, while GUDID is the database used to maintain key device identification information.
Requirements can vary depending on the device, its regulatory status, the responsible labeler, and applicable exceptions or alternatives. The issuing agency, identifier assignment, label requirements, database submission, and record maintenance should be considered as part of the overall compliance process.
A GUDID record does not replace other applicable FDA requirements. Depending on the device, separate obligations relating to establishment registration, device listing, premarket notification or approval, quality management, and other regulatory matters may also apply.
Frequently Asked Questions About GUDID & UDI Setup
Visit our dedicated Frequently Asked Questions page for more information about UDI requirements, GUDID data preparation, device labelling, submission support, and medical device regulatory considerations.
Prepare Your Device Identification Information
Organise your medical device identification information with support from Cosmetic Compliance Nest. Our GUDID & UDI Setup service helps businesses review applicable requirements, prepare relevant device data, and plan the next steps for database and labelling activities.
Important Disclaimer
Cosmetic Compliance Nest provides independent regulatory consultancy and documentation support. It is not affiliated with or endorsed by the US Food and Drug Administration (FDA) or any UDI issuing agency. UDI and GUDID obligations depend on the device and applicable regulatory requirements, including any relevant exceptions or alternatives. This service does not guarantee FDA clearance, approval, registration acceptance, GUDID publication, or a particular compliance outcome. The client remains responsible for the accuracy of supplied information and for meeting applicable regulatory obligations. Issuing-agency fees, barcode generation, label artwork changes, account fees, and third-party charges are excluded unless expressly included in the agreed service terms.