24 Feb A Map for Navigating the Global Unique Device Identifier Database
This newsletter is the third in a series of papers addressing the challenges of UDI implementation and the best way to maneuver through the process. Here we will discuss the mechanics of obtaining a UDI and entering the data in the FDA’s Global Unique Device Identifier Database (GUDID).
The Global Unique Device Identification Database is administered by the FDA. Medical Device Manufacturers are responsible for entering information into the database on each device that is applicable to the UDI Regulation. The information that is entered is specific to a device name and type (device identifier or DI) and includes attributes that relate to the regulatory clearance and classification of the device Specific information related to lot or batch (product identifier or PI) is not an attribute that is recorded in the database. Certain information entered into the database will be made publically available. The FDA hopes to make the GUDID publically available by spring 2015. (1)
GUDID Data Elements
The FDA created a convenient list of data elements that are necessary for a GUDID submission. This table can be accessed by going to GUDID Data Elements Reference Table. Most of these data elements are already available to companies, however there are some that may not be immediately accessible. These elements will need to be collected before a submission to the GUDID is possible. Below are the beginning steps to preparing for a GUDID submission. (1)
Step One: Determine the total number of DIs you will need
This will be based on the list that your company should create which contains the product codes and how many unique devices your company labels. (2) Refer to BBA’s January 2015 Newsletter for a discussion of how to create this list.
Step Two: Select Issuing Agency
Currently there are three FDA accredited UDI issuing agencies. Your company can contact any of these agencies to generate device identifiers. These can range in price from $250-$10,000 based on the code number of the device, with yearly fees ranging from $0-$2100. The accredited agencies are:
Step Three: Obtain a DUNS number
DUNS stands for Data Universal Numbering System. This is a nine digit number assigned by Dun & Bradstreet and act to identify the labeler organization in the GUDID. The DUNS number is free if you can wait for 30 days, otherwise you must pay a fee.
Labelers need to be sure that the information associated with DUNS matches what is on the device label and what will be your GUDID account registration name and address with the FDA. Visit the Dun & Bradstreet website to start the process for obtaining a DUNS number.
Step Four: Purchase Account for GMDN with GMDN Agency
GMDN stands for Global Medical Device Nomenclature (GMDN). You will need to purchase a GMDN account in order to obtain active GMDN preferred terms for your devices. Go to www.gmdnagency.org. If your company only markets devices in US, your company can use FDA PT Codes for free, but these will not be useful outside of the US.(1)
You will also need to ensure that the device listings with the FDA (through the FDA FURLS system) are correct.
Step FIVE: Select Submission Method
There are two submission methods available for entering data attributes into the GUDID system: either GUDID HL7 SPL or through the FDA web interface. See Figure 1 below for the basic work flow of the two options.
- The GUDID HL7 SPL Submission Option: This option is for labelers who have too many codes to submit the codes manually. It uses the FDA Electronic Submissions Gateway (ESG) to submit to data in the form of a single XML document. HL7 stands for Health Level 7, and SPL stands for Structured Product Labeling. (3)
- Register with the Electronic Submission Gateway (ESG). There is a User Guide available to assist in understanding the system.
- Create a GUDID Test Account (Testing is required for this form of submission, to be sure that the information is entered correctly into the XML document)
- Complete HL7 SPL testing
- Continue to step seven.
- Web Interface: This option is for labelers who have only a few codes to enter and can submit them one DI record at a time. Data is entered directly into the GUDID database.(3)
- It is a good idea to become familiar with the GUDID system by creating draft records.(1)
Figure 1: Flowchart illustrating GUDID submission options and the Search and Retrieval Options available to Public Users (2)
Step SIX: Create GUDID database account
The GUDID account is free; however you must first request an account from the FDA. To do this, you must submit a GUDID Account Inquiry. The FDA will respond by emailing a PDF GUDID Account Request document. Fill this form out and email it back to the FDA GUDID help desk. (4) On this form, it will be necessary to indicate:
- the official regulatory representative
The FDA will respond with your new GUDID account information.
Step Seven: Finally, you are ready to submit your DI records to the FDA!
Currently the GUDID database is open to labelers of implantable, life-supporting and life-sustaining (I/LS/LS) devices and labelers of class III devices. (1) Other labelers can prepare up to step six. Check the FDA’s GUDID website for announcements of when the database will be opened to labelers of Class II and I devices.
What This Means to You
Unique Device Identifiers offer a great many benefits to both manufacturers and users of medical devices. However, they also require an investment in time and money to properly implement. If done right, the process can help to improve internal device tracking and data quality. By following the process and using resources provided here and by the FDA, your company can navigate a path to successful UDI implementation and improved quality control. Boston Biomedical Associates can offer assistance in obtaining the puzzle pieces, such as the DUNS number and GMDN accounts, and helping to develop your DI Regulatory Database. We can help make sure that you will be ready to submit to the GUDID database when the time comes. Feel free to contact us for more information.
- Konduri, Indira R. Getting Ready for GUDID. 2015. http://www.fda.gov/downloads/Training/CDRHLearn/UCM430217.pdf
- U.S. Department of Health and Human Services. Global Unique Device Identification Database (GUDID). 2014. http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM369248.pdf
- U.S. Food and Drug Administration. Global UDI Database (GUDID). 2015. http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/GlobalUDIDatabaseGUDID/default.htm
- U.S. Food and Drug Administration. Request a GUDID Account. 2015. http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/GlobalUDIDatabaseGUDID/ucm416113.htm