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GUIDANCE DOCUMENT

Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices, Direct Marking, and Global Unique Device Identification Database Requirements for Certain Devices Guidance for Industry and Food and Drug Administration Staff July 2022

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2017-D-6841
Issued by:
Guidance Issuing Office
Center for Biologics Evaluation and Research
Center for Devices and Radiological Health

FDA has updated this guidance to include FDA’s compliance policy regarding Global Unique Device Identification Database (GUDID) submission requirements for certain class I devices considered consumer health products. Specifically, FDA does not intend to enforce the GUDID submission requirements under 21 CFR 830.300 for class I devices considered to be consumer health products that are required to bear a UDI on their labels and device packages. Additionally, FDA does not intend to enforce the GUDID submission requirements under 21 CFR 830.300 for class I and unclassified devices, other than implantable, life-supporting, or life-sustaining (I/LS/LS) devices, regardless of whether they are consumer health products, before December 8, 2022 (an additional 75 calendar days).

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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:

Dockets Management
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.

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