Medical Devices

Compliance Dates for UDI Requirements

The table below outlines key compliance dates established by FDA in conjunction with the UDI final rule.

Compliance Dates Established by FDA in Conjunction with UDI Final Rule

Compliance Date Requirement
1 year after publication of the final rule (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).
2 years after publication of the final rule (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.
3 years after publication of the final rule (September 24, 2016) Class III devices 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.
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.
5 years after publication of the final rule (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.
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 all devices, including devices that have been excepted from UDI labeling requirements, 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).
7 years after publication of the final rule (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.
Compliance dates for all other provisions of the final rule.  Except for the provisions listed above, FDA requires full compliance with the final rule as of the effective date that applies to the provision.

UDI Enforcement Discretion Applying to Class I and Unclassified Devices1,2

FDA has issued a guidance establishing enforcement discretion that applies to FDA established compliance dates for certain class I and unclassified devices as set out in Figure 1 below.

Type of Device 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 FDA does not intend to enforce Direct Mark requirements (21 CFR 801.45) before:
Class 1 and unclassified devices manufactured and labeled on or after September 24, 2018 September 24, 2020 September 24, 2022
Finished class 1 and unclassified devices manufactured and labeled before September 24, 2018 September 24, 2021 September 24, 2022

Figure 1

For more information, see “Letter to Device Labelers on UDI Compliance Dates for Class I and Unclassified Devices – June 2, 2017”.

Implantable, Life-Saving, and Life-Sustaining Devices

List of medical devices the FDA classifies as implantable, life-saving, and life-sustaining for purposes of section 614 of FDASIA amending section 519(f) of the FDC Act, March 2015 (PDF - 84KB). Labelers may refer to this link as a guide, but it is not a definitive list of implantable, life-saving, and life-sustaining devices subject to the September 24, 2015 UDI compliance date.

We recommend that labelers search the CDRH Product Classification database for the most current information on FDA product codes to determine if the devices within an FDA product code are considered implantable, life-saving (life-sustaining), or life-supporting.

The labeler should also evaluate the characteristics of the device and look to the device’s intended use to determine whether a particular device is life-saving, life-sustaining or implantable and follow the appropriate compliance dates and rules. For the purposes of determining the applicability of UDI requirements, refer to 21 CFR 860.3(e) for the definition of life-supporting or life-sustaining device, and refer to 21 CFR 801.3 for the definition of implantable device.

There are also a number of general exceptions from the requirement for the label of a medical device to bear a UDI.

For more information about UDI Exceptions, Alternatives, and Time Extensions, please see the UDI Exceptions, Alternatives, and Time Extensions webpage.

 

1 Does 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).

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.


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