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Guidance Issuing OfficeCenter for Devices and Radiological HealthCenter for Biologics Evaluation and Research
FDA has developed this draft guidance for labelers of class I devices to revise “Section III. Policy On Standard Date Formatting, UDI Labeling, and GUDID Submission Requirements for Class I and Unclassified Devices” 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”) that was issued on July 1, 2020. When this draft guidance is finalized, the updates in Section III of this draft guidance would supersede the recommendations in Section III of the 2020 UDI Compliance Policy Guidance. This draft guidance explains that there are certain class I devices for which FDA does not intend to enforce Global Unique Device Identification Database (GUDID) submission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 under 21 CFR 830.300, and describes how a labeler of a class I device can determine whether its device is within the scope of this compliance policy.
FDA plans to incorporate the final version of this draft guidance into “Section III. Policy On Standard Date Formatting, UDI Labeling, and GUDID Submission Requirements for Class I and Unclassified Devices” of the 2020 UDI Compliance Policy Guidance. The remainder of the 2020 UDI Compliance Policy Guidance, with the exception of technical edits for consistency with the newly amended Section III, would not be substantively changed.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2017-D-6841.