The 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, the FDA requires full compliance with the final rule as of the effective date that applies to the provision.

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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).

UDI Policy Regarding Certain Class I and Unclassified Devices:  The FDA issued a guidance on its policy regarding compliance dates for class I and unclassified devices that are not implantable, life-supporting, or life-sustaining.  The guidance explains that, at this time, the FDA does not intend to enforce UDI labeling (21 CFR 801.20 & 801.50), Direct Mark (21 CFR 801.45), GUDID Data Submission (21 CFR 830.300), and Standard Date Format (21 CFR 801.18) requirements before September 24, 2022.

Note:

• The compliance policy described in the guidance 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).

For more information:

• Guidance: Policy Regarding Compliance Dates for Class I and Unclassified Devices and Certain Devices Requiring Direct Marking

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-Supporting, 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-Supporting, and Life-Sustaining

The FDA recommends that device labelers:

• Check the 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 such devices subject to the September 24, 2015 UDI compliance date.
• 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-supporting, or life-sustaining.
• Evaluate the characteristics of the device and look to the device’s intended use to determine whether a particular device is implantable, life-supporting, or life-sustaining, 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.

*Section 519(f) of the FD&C Act uses the terminology “implantable, life-saving, or life-sustaining.” The FDA clarified in proposing the UDI rule that it would be using the terminology “implantable, life-supporting, or life sustaining” to be consistent with existing FDA terminology. See 77 FR 69394.