FDA Guidance Compliance Dates for UDI Requirements

Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices and Certain Devices Requiring Direct Marking

FDA Guidance for Industry and Food and Drug Administration Staff

Today (June 30, 2020), the U.S. Food and Drug Administration (FDA) issued the guidance entitled “Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices and Certain Devices Requiring Direct Marking.”  This guidance is immediately in effect.

This guidance describes FDA’s intention with regard to enforcement of these requirements for class I and unclassified devices.

This guidance also describes FDA’s direct mark compliance policy for class III, LS/LS, and class II devices that are non-sterile, that are manufactured and labeled prior to their applicable direct mark compliance date, and that remain in inventory, as well as for class I and unclassified devices that are not LS/LS devices, that are non-sterile, that are manufactured and labeled prior to September 24, 2022, and that remain in inventory. 

In the guidance, several key elements of the FDA’s policy are included regarding Unique Device Identification (UDI) compliance dates.  It should be noted that the FDA:
  • Does not intend to enforce Unique Device Identification labeling compliance for certain class I and unclassified devices that are not implantable, life-supporting, or life-sustaining before September 24, 2022.
  • Has not altered other policies that were conveyed in a previous (November 2018) version of the guidance.

The following compliance dates are established for class I and unclassified devices, other than implantable, life-supporting, or life-sustaining (I/LS/LS) devices.  

  • September 24, 2018, for the following requirements:
    • Standard date formatting (21 CFR 801.18),
    • Labeling (21 CFR 801.20, 21 CFR 801.50), and
    • Global Unique Device Identification Database (GUDID) data submission (21 CFR 830.300); and
  • September 24, 2020, for direct mark requirements (21 CFR 801.45).

Download the FDA guidance in PDF below.

UDI Policy Regarding Compliance Dates for Class I and Unclassified Devices and Certain Devices Requiring Direct Marking (31 downloads)

Last Updated: 2020-06-30

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