FDA: UDI Compliance Dates

The “immediately-in-effect” guidance document lays out policy on compliance dates for class I and unclassified Devices.

The “immediately-in-effect” guidance document lays out policy on compliance dates for class I and unclassified Devices.
The “immediately-in-effect” guidance document lays out policy on compliance dates for class I and unclassified Devices.

The FDA released a guidance document today, "Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices."

The accompanying announcement notes that the guidance is for industry and staff to understand the FDA’s intentions regarding enforcement, as well as “explain the thinking behind FDA’s enforcement discretion policy for labeling, Global Unique Device Identification Database (GUDID) data submission, standard date formatting, and direct mark requirements for class I and unclassified devices, as first described in June 2017.”

FDA’s enforcement policy includes the following:

  • The FDA will not enforce standard date formatting, labeling, and GUDID data submission requirements for class I and unclassified devices before September 24, 2020;
  • They will not enforce direct mark requirements for class I and unclassified devices before September 24, 2022; and
  • They will not enforce standard date formatting, labeling, and GUDID data submission requirements until September 24, 2021, and direct mark requirements until September 24, 2022 for finished devices manufactured and labeled prior to September 24, 2018.

(The enforcement policies do not apply to class I and unclassified implantable, life-supporting or life-sustaining (I/LS/LS) devices, which had an established compliance date of September 24, 2015.)

The guidance document is in effect immediately, but is still open for comments at www.regulations.gov.

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