Medical device and device packages identification (ICS 11.040)

Unique Device Identification System

The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of the draft guidance entitled "Select Updates for Unique Device Identification: Policy Regarding Global Unique Device Identification Database Requirements for Certain Devices; Draft Guidance for Industry and Food and Drug Administration Staff." This draft guidance explains that there are certain class I devices for which FDA does not intend to enforce Global Unique Device Identification Database (GUDID) submission requirements and describes how a labeler of a class I device can determine if its device is one of these devices in the revised section III of this draft guidance. When this draft guidance is finalized, the updates in section III of this draft guidance would supersede the recommendations in section III of the guidance "Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices and Certain Devices Requiring Direct Marking" ("2020 UDI Compliance Policy Guidance," available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/select-updates-unique-device-identification-policy-regarding-global-unique-device-identification). This draft guidance is not final nor is it in effect at this time.

DATES: Submit either electronic or written comments on the draft guidance by 13 December 2021 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.