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  1. Unique Device Identification System (UDI System)

Compliance Dates for UDI Requirements

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FDA established key compliance dates in conjunction with the Unique Device Identification System final rule.

Compliance dates for all other provisions of the final rule. Except for the provisions listed below, FDA requires full compliance with the final rule as of the effective date that applies to the provision.


Requirements by Device Type

Devices Excepted From or Not Subject to UDI Labeling Requirements

Compliance Date Requirements
September 24, 2018 Dates on the labels of devices, excepted from or not subject to the UDI labeling requirements, must be formatted as required by § 801.18.

Class I and Unclassified Medical Devices

Compliance Date Requirements
September 24, 2020 Class I devices, and devices that have not been classified into class I, class II, or class III that are required to be labeled with a UDI, must a bear UDI as a permanent marking on the device itself if the device is a device intended to be used more than once and intended to be reprocessed before each use. § 801.45.
September 24, 2018 The labels and packages of class I medical devices and devices that have not been classified into class I, class II, or class III must bear a UDI. § 801.20.
Dates on the labels of these devices must be formatted as required by § 801.18.
Data for class I devices and devices that have not been classified into class I, class II, or class III that are required to be labeled with a UDI must be submitted to the GUDID database. § 830.300.
Class I stand-alone software must provide its UDI as required by § 801.50(b).

FDA issued a guidance establishing enforcement discretion that applies to the compliance dates for Class I and unclassified devices:

Device Type Requirement Date
Class I and unclassified devices manufactured and labeled on or after September 24, 2018 FDA does not intend to enforce UDI labeling (21 CFR 801.20 & 801.50), GUDID Data Submission (21 CFR 830.300), and Standard Date Format (21 CFR 801.18) requirements before: September 24, 2020
FDA does not intend to enforce Direct Mark requirements (21 CFR 801.45) before: September 24, 2022
Finished Class I and unclassified devices manufactured and labeled before September 24, 2018 FDA does not intend to enforce UDI labeling (21 CFR 801.20 & 801.50), GUDID Data Submission (21 CFR 830.300), and Standard Date Format (21 CFR 801.18) requirements before: September 24, 2021
FDA does not intend to enforce Direct Mark requirements (21 CFR 801.45) before: September 24, 2022

Notes:

  • These enforcement discretion dates do not apply to Class I or unclassified implantable, life-supporting or life-sustaining devices; labelers of these devices must already be in compliance with UDI requirements. Class I CGMP-exempt devices are excepted from UDI requirements. 21 CFR 801.30(a)(2).
  • Consistent with 21 CFR 801.30(a)(1), finished class I and unclassified devices manufactured and labeled before September 24, 2018, are excepted from the UDI labeling and GUDID submission requirements by regulation until September 24, 2021.

For more information:

Class II Medical Devices

Compliance Dates Requirements
September 24, 2018 A class II device that is required to be labeled with a UDI must bear a UDI as a permanent marking on the device itself if the device is a device intended to be used more than once and intended to be reprocessed before each use. § 801.45.
September 24, 2016 The labels and packages of class II medical devices must bear a UDI. § 801.20.
Dates on the labels of these devices must be formatted as required by § 801.18.
Class II stand-alone software must provide its UDI as required by § 801.50(b).
Data for class II devices that are required to be labeled with a UDI must be submitted to the GUDID database. § 830.300.

Class III Medical Devices and Devices Licensed under the Public Health Service Act (PHS)

Compliance Dates Requirements
September 24, 2016 A class III device that is required to be labeled with a UDI must bear a UDI as a permanent marking on the device itself if the device is a device intended to be used more than once and intended to be reprocessed before each use. § 801.45.
September 24, 2014 The labels and packages of class III medical devices and devices licensed under the Public Health Service Act (PHS Act) must bear a UDI. § 801.20.
Dates on the labels of these devices must be formatted as required by § 801.18. Data for these devices must be submitted to the GUDID database. § 830.300.
A 1-year extension of this compliance date may be requested under § 801.55; such a request must be submitted no later than June 23, 2014.
Class III stand-alone software must provide its UDI as required by § 801.50(b).

Implantable, Life-Saving, and Life-Sustaining Medical Devices

Compliance Date Requirements
September 24, 2015 The labels and packages of implantable, life-supporting, and life-sustaining devices must bear a UDI. § 801.20.
Dates on the labels of these devices must be formatted as required by § 801.18.
A device that is a life-supporting or life-sustaining device that is required to be labeled with a UDI must a bear UDI as a permanent marking on the device itself if the device is intended to be used more than once and intended to be reprocessed before each use. § 801.45.
Stand-alone software that is a life-supporting or life-sustaining device must provide its UDI as required by § 801.50(b).
Data for implantable, life-supporting, and life-sustaining devices that are required to be labeled with a UDI must be submitted to the GUDID database. § 830.300.

How to Determine if a Device Is Implantable, Life-Saving, and Life-Sustaining

The FDA recommends that device labelers:



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