This blog, “What is the GUDID?” reviews the basics of the database, do we need a GUDID account?, how data is submitted, what information is needed and more.
What is the GUDID?
FDA, in creating the Unique Device Identifier (UDI), was looking to improve the postmarket surveillance process, which included developing a database, to be used by the healthcare community and the public to obtain critical information on the medical devices they use. The Global UDI Database (GUDID – pronounced Good-I-D) is a repository for key device identification information. It will not include any patient information. This key information – 62 different data elements (see below) – is limited to Device Identifiers (DI) and Labeler information. Every Labeler of medical devices is required to have a UDI and submit this information to the GUDID.
Changes from the proposed rule impacting GUDID
In the proposed rule, FDA did not want to use Global Medical Device Nomenclature (GMDN) Preferred Term (PT) codes. Unfortunately, the GMDN PT codes are not free and a subscription is required to access the GMDN database. FDA was able to negotiate an agreement with the GMDN Agency to allow Labelers access to the GMDN PT codes. These codes will only be accessible to Labelers who enter device information using FDA’s Web Interface submission process. A word of caution; the GMDN Agency is continually adding and updating these codes. Companies submitting data via HL7 SPL (see below) will need to subscribe to the GMDN Agency in order to gain access to these codes.
Another change deals with MRI compatibility. If you claim your device is MR Safe, MR Conditional or MR Unsafe, then this information is now required as part of the submission to GUDID.
A new version of the GUDID Implementation Specification (Version 1.2.1, released April 11, 2014) is now available. FDA Global UDI Database Web Site
Do we need a GUDID account?
In order to submit medical device key information, Labelers need to request an account through the FDA GUDID website. The Labeler Organization may have more than one GUDID account. A Duns and Bradstreet (DUNS) number for the company location is used to identify each GUDID account.
There are three (3) levels – Organization (which may also be a Labeler), Labeler and Third-Party (entity authorized to submit GUDID information on behalf of Labeler). Each GUDID account must have:
- One (1) Regulatory Contact
- One (1) Coordinator (manages Labeler Data Entry users)
- One (1) Labeler Data Entry user (day-to-day data entry)
- One (1) Labeler DUNS number
Labeler DUNS number must match name and address on the device label.
Production Identifiers (PI) are not entered in to the Database (just PI flags to indicate which PI are on the label).
How data is submitted to GUDID
There are two standard-based methods to submit data: 1) structured input via a web interface, and 2) the Health Level 7 Structured Product Labeling (HL7 SPL) process. The first method, using a web-based interface, will work well for up to 200 total records. If you attempt to input more than 200 records the input becomes overwhelming and you will need to use the HL7 SPL process. HL7 SPL is in XML format and uses the FDA Electronic Submission Gateway (ESG) as the pathway to upload data into GUDID. Both submission methods are one DI record at a time. There is no batch option available.
You are also able to use third-parties to submit data. GS1 GDSN (Global Data Synchronization Network) is one example; there are others as well. Or you could build your own submission tool.
There are three (3) states of entry –
- Draft DI – only available via Web interface (Draft DI will be available for 180 days)
- Unpublished – has passed all the business rules
- Published – is now searchable
Currently, the GUDID search and retrieval options are not currently operational, as FDA is waiting until sufficient data has been entered to turn this feature on.
What information do I need?
There are 60-plus data attributes that need to be provided. Some of the fields are automatically filled in by the GUDID system, based on information that is entered. For instance, the Labeler Name and Address are pulled from the DUNS database, based on the DUNS number entered. An entry can have more than one Device Identifier. This is usually the case if you have used different Issuing Agencies. Attributes on label/package and the values submitted should match. GUDID also has controlled vocabulary and built-in business rules that will continually check what data is input.
Controlled vocabulary are DUNS #, GMDN code and FDA Product Codes.
Examples of Business Rules are:
- All required data elements must be provided
- Validating specific elements – FDA Listing #, etc.
- Data constraints on specified elements – Publish date must always be >= TODAY
- There are other additional business rules
Also, a DI can never be reused, even if it is discontinued. It will remain in GUDID, but marked as “Not in Commercial Distribution.”