As we posted earlier, FDA released a final rule implementing a “unique device identifier” (UDI) system on September 24, 2013. FDA also issued a draft guidance document, Global Unique Device Identification Database (GUDID), on the same date.
The draft guidance is intended to provide information about submitting data to the database for device “labelers,” i.e., the entities who will be responsible for these submissions. The final rule defines a labeler as any person (1) who causes a label to be added to a device with the intent to commercially distribute the device without further changes to the label or (2) who causes a label to be replaced or modified with the intent to commercially distribute the device without further label changes other than the addition of distributor name and contact information.
The draft guidance contains technical details on how labelers will create GUDID accounts and submit information to the database. Key points on the mechanics of the database include:
- Labelers have two submission options: (1) GUDID Web Interface and (2) HL7 SPL xml file submission. The GUDID Web Interface module enables creation of GUDID accounts, submission of device identifier (DI) records, and search and retrieval of device information. The HL7 SPL Submission option enables companies to electronically submit device information one DI record at a time. Companies that submit using the HL7 SPL option are subject to the requirements of 21 C.F.R. Part 11.
- For both submission options, labelers must have a GUDID account for submission. (GUDID accounts are not required for search and retrieval of published information.) Labelers can have multiple GUDID accounts, but each account must have only one regulatory contact. Labelers may designate third-party submitters, such as contractors or vendors, for GUDID submissions.
- A UDI consists of a DI and a production identifier (PI), which includes one or more of the lot/batch number, serial number, expiration date, or date of manufacture. A record in the GUDID, however, will consist of only the DI and certain associated data attributes that are listed in Appendix B of the guidance.
- All DIs will be checked for uniqueness in the GUDID. Once used, a DI can never be reused, even if the product is no longer in commercial distribution.
- Each DI record in the GUDID will require entry of one or more Global Medical Device Nomenclature (GMDN) Preferred Term codes. This is a system maintained by the GMDN Agency, a non-profit company based in the UK. Companies must obtain a license to access the Global Medical Device Nomenclature vocabulary and select Preferred Term codes for submission to the GUDID.
- DI records can exist as draft, unpublished, and published. Once published, all attributes of the record except Publish Date can be edited for a seven-day grace period. After this period, editing is limited.
FDA notes that, as the agency learns from the initial roll-out and implementation, it will continue making database enhancements to improve user experience, build in better validation rules, and make other necessary changes.