Update on UDI Requirements

The FDA has published a draft Guidance for Industry with the title "Selected Update for Unique Device Identification: Policy Regarding Global Unique Device Identification Database Requirements for Certain Devices".  

This short draft guidance contains only seven pages with three chapters

  • 1) Introduction
  • 2) Background
  • 3) Revised Section III

The target group are labelers of class I devices. For these labelers the guidance "Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices and Certain Devices Requiring Direct Marking" (also called "2020 UDI Compliance Policy Guide") applies from 1st July 2020. The relevant equirements are listed in Section III of FDA´s Policy On Standard Date Formatting, UDI Labeling and GUDID Submission Requirements for Class I and Unclassified Devices.

This draft guidance is supposed to update the section III  of the "2020 UDI Compliance Policy Guide". Its aim is to explain that there are certain class I devices for which the FDA does not intend to enforce Global Unique Device Identification Database (GUDID) submissions. It further describes how labelers of a class I devices can determine wether their device is within the scope of this compliance policy.

Details regarding class I devices considered as consumer health care and not as consumer health care products and for unclasssified devices are explained in the chapter III of the draft guidance.

The draft can be commented within 60 days after its publication on October 13,  2021 and is available on FDA´s website.

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