FDA Updates GUDID Guidance: GMDN Codes and Enhancements

The FDA has issued updates to the Global Unique Device Identification Database (GUDID) guidance, reflecting changes to the Global Medical Device Nomenclature (GMDN) field.

Key Updates on the GUDID Guidance Include:

• • Removal of FDA Preferred Term (PT) Codes: Users are encouraged to switch to GMDN Codes, which are now freely accessible.
  • Enhanced user experience: Improvements in validation rules and user feedback integration.
  • Data quality focus: Emphasis on optimizing data quality and utility in GUDID for public health benefits.
  • Submission options: Device labelers can submit data via manual entry or bulk uploads through the FDA Electronic Submissions Gateway.

For more details, visit the FDA GUDID page here.

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This guidance outlines the latest updates for the GUDID guidance under the FDA. For help navigating these regulations, contact us today.

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