FDA Issues Minor Updates to Final Guidance on Global Unique Device Identification Database
- eastanglian
- 2024年12月18日
- 読了時間: 1分
Today, the U.S. Food and Drug Administration (FDA) issued minor updates to this final guidance: Global Unique Device Identification Database (GUDID) - Guidance for Industry and Food and Drug Administration Staff.
This guidance update reflects upcoming changes to the Global Medical Device Nomenclature (GMDN) field in GUDID and other minor clarifications. The FDA will be removing FDA Preferred Term (PT) Codes from GUDID. These are no longer necessary because anyone can now access and use GMDN Codes for free.
The FDA will let users know when the changes to GUDID are implemented. Once the FDA PT Codes are removed, GUDID users will only be able to use GMDN Codes.
The FDA encourages GUDID users to switch from FDA PT Codes to GMDN Codes now.
GUDID enhancements to improve user experience, build in better validation rules, and other changes may continue as we receive user feedback. We intend to periodically update this guidance document to reflect system changes and enhancements.
Each Device Identifier (DI) record is subject to GUDID business rules to help ensure data quality. GUDID business rules for each data attribute are provided in the GUDID Data Elements Reference Table.
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