GUDID updates

FDA Updates GUDID Guidelines:

Transition to GMDN Codes

Updated FDA Guidelines for the Global Unique Device Identification Database (GUDID)

The U.S. Food and Drug Administration (FDA) has released a new version of its guidelines for the Global Unique Device Identification Database (GUDID). These changes aim to optimize the use of the GUDID database and further improve data quality. The focus is on transitioning from FDA Preferred Term (PT) codes to GMDN codes and introducing enhanced user experience features.

What Has Changed?

1. Removal of FDA PT Codes:
   • The FDA will remove the previously used PT codes from GUDID. These codes will be replaced by the Global Medical Device Nomenclature (GMDN), which has been freely available since 2019.
   • Moving forward, all GUDID users must exclusively use GMDN codes.
2. Recommendation to Use GMDN Codes:
   • The FDA strongly recommends users to transition to GMDN codes as early as possible. Resources and guides on how to obtain a GMDN code are already available.
3. Improvements in User Experience:
   • Adjustments to the GUDID interface will make navigation and data entry more intuitive.
   • New validation rules will be implemented to minimize entry errors and ensure data quality.
4. Planned Regular Updates:
   • The FDA plans to regularly update its guidelines to reflect system changes and enhancements. Further adjustments may follow based on user feedback.

What Does This Mean for Companies?

The transition to GMDN codes affects all companies registering medical devices in GUDID. Manufacturers must ensure their products are correctly classified and switch to GMDN codes early to ensure seamless database usage.

The new validation rules and improved user interface will simplify device identification management and enhance data quality.

How We Can Support You

We are here to assist you with any questions regarding the FDA changes and the GMDN transition. If you need support in adapting your device classifications or using GUDID, feel free to contact us. Our team will help you efficiently implement the new requirements.