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

Information

Type

Guidance

Regulated products

Biologics, Medical Devices

Topics

Labeling, UDI

Published

July 25, 2022

Last updated

July 22, 2022

Description

Guidance document on compliance dates, direct marking, and global UDI database requirements for certain devices, focusing on labeling and UDI.

Organization

Country / Region

United States

License

Other (Public Domain)

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