The Database for Unique Device Identification
When systems such as Unique Device Identification (UDI) roll out, they create huge amounts of data. This necessitates a robust and scalable database, which is just what the U.S. Food and Drug Administration (FDA) is doing with the Global Unique Device Identification Database (GUDID).
Working in conjunction with UDI, the publicly searchable database will play the crucial role of a reference catalog for all devices with an identifier. As per FDA rules, all medical devices will carry this unique identifier containing important product information.
What the Database Does and Doesn’t Contain
The database will only contain the device identifier (DI), the principal source for device information within the GUDID. Production Identifiers (PI) will not be stored on the GUDID. Nonetheless, production identifier flags will be included in the database, indicating the label’s PI elements.
GUDID Information Submission
There are two ways to submit device identification information to the GUDID:
- GUDID Web Interface: The secure web interface allows a structured approach to submission, adding DI records one by one. Labelers will need to create a GUDID account to input device information via the web interface.
- HL7 SPL Submission: SPL stands for Structured Product Labeling. This method involves device information being submitted using xml files. In addition to getting a GUDID account, labelers will need to create an Electronic Submission Gateway (ESG) account and complete ESG and GUDID testing.
Initially, only labelers of devices licensed under the Public Health Service (PHS) Act and class III medical devices will be allowed access to submit device information to the GUDID.
GUDID Information Search & Retrieval
Public access to the GUDID will be enabled from day one. Moreover, the database will allow two methods to retrieve DI information:
- Search & retrieval information using a secure web interface
- System-to-system search and retrieval using web service.
No GUDID accounts are required for searching for and retrieving information.
Currently, the database’s search functionality is disabled. As the compliance timeline unfolds, more data will be added to the GUDID. Once a significant dataset is created, the search functionality will be enabled.
The FDA has issued a draft guideline document for the GUDID. This draft will facilitate the labelers’ information submission process. Important GUDID concepts ranging from user roles and accounts to package configurations and data attributes are covered in the draft guidance. To encourage comments and suggestions, the FDA has included in the guidance instructions on how to submit comments.
The GUDID is off to an excellent start. With feedback-driven improvements and other well thought-out enhancements, the database will certainly facilitate a smooth and swift adoption of UDI across the U.S.