FDA updates GUDID final guidance
The US Food and Drug Administration (FDA) issued an updated final guidance on Tuesday addressing the submission of unique device identifiers (UDIs) to the Global Medical Device Nomenclature Database (GUDID).This update features minor revisions from the previous guidance, including the removal of FDA Preferred Terms (FDA PT) or codes from the database, as they are no longer needed. The document updates a final guidance originally issued in June 2014.
The guidance update “reflects upcoming changes to the Global Medical Device Nomenclature (GMDN) field in GUDID and other minor clarifications. Since April 2019 the GMDN Agency allows access to GMDN Terms without a paid membership. Therefore, the option to use FDA Preferred Term (PT) Codes is no longer necessary and FDA intends to remove them from GUDID. Reference to the FDA PT codes is being removed from this guidance and GUDID users must use GMDN codes.”
Another change emphasizes a lifecycle approach to ensure that device identifier (DI) records are adequately maintained. The section on maintaining GMDN codes now states that "labelers are responsible for ensuring that their DI record information is accurate and up-to-date throughout the Total Product Lifecycle (TPLC) of the device."
The guidance indicates that additional database “enhancements” may be implemented to improve user experience, establish better validation rules, and incorporate other changes based on user feedback.
All medical device labels and packaging must include a UDI, unless specifically exempt, said the guidance. This requirement also applies to combination products that have a device component, convenience kits, in vitro diagnostic (IVD) products, and products derived from human cells and tissues, including cellular and tissue-based products (HCT/Ps) that are regulated as devices. Standalone software is also included in this requirement.
The UDI consists of two parts: a device identifier (DI) which is a mandatory, fixed portion of a UDI that identifies the labeler and the specific version or model of a device; and a production identifier (PI) which is a conditional, variable portion of a UDI that includes the lot or batch number, the serial number of a specific device, the expiration date, the date the device was manufactured; and for an HCT/P regulated as a device, a distinct identification code.
The GUDID database only includes the DI, which is the primary key for accessing device information in the database. PIs are not submitted to the GUDID. Instead, the database features production identifier flags to indicate which PI attributes are present on the device label.
The guidance covers GUDID key concepts, the GUDID modules, and GUDID submission requirements. Appendix A lists the GUDID packaging information example, Appendix B has a GUDID data elements reference table, Appendix C includes the UDI formats used by FDA accredited issuing agencies, and Appendix D lists GUDID attributes mapped to a fictitious medical device label.
Guidance
