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New FDA Standards for Unique Device Identifier Labels


Most industries around the world have strict labeling standards and regulations, but almost nowhere are the specifics of labels more scrutinized than in the medical industry. Each and every piece of equipment that is used to facilitate the treatment and care of a patient needs to carry a label. And the slightest deviation from stipulated standards can result in strict penalties.

To improve patient safety, modernize device postmarket surveillance and encourage medical device innovation, the FDA’s Unique Device Identifier labels policy was created. This policy requires a unique device identifier (UDI) to be included on device labels and packages by device labelers.

The table below outlines key compliance dates in the 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.
Source: http://www.fda.gov

Anatomy of a UDI Label

A UDI is a unique numeric or alphanumeric code that consists of a device identifier (DI) and a production identifier (PI) and all UDIs are to be issued under a system operated by an FDA-accredited issuing agency.

Anatomy of an UDI Label

The Unique Device Identifier (UDI) Rules & Regulations 

  • The DI is mandatory and identifies the labeler and the specific version of a model of a device
  • The PI is a variable portion of the UDI which can include the lot or batch number when a device was manufactured, the devices’ serial number, the devices expiration date and the date the device was manufactured.
  • The UDI labels should be readable – both by humans and by computers
  • The device manufacturers will be in charge of marking their equipment with UDI labels and it is the duty of the label creators or facilitators to upload device information to the Global Unique Device Identification Database (GUDID) for unrestricted access by healthcare stakeholders.
  • The GUDID which is supported by the UDI labels will allow doctors to be able to download instructions and guidelines of device use and make the most of features and functionalities for optimum patient care.

How Does Tailored Label Products Play Its Part in the UDI Revolution?

Tailored Label Products has been the gold standard in the world of labeling for years. Accurate, capable of withstanding harsh environmental conditions and always legible, vibrant and durable. Our products have been used on vials, devices and containers for the medical industry.  Our capabilities and technical expertise allow us to meet UDI rules and regulations by printing labels with the right construction for the application and required information for UDI correctly included.

Also to help maintain the integrity of the unique IDs in the supply chain, TLP offers advanced features such as a dual label verification system that allows a technician to remove the first layer of the label for documentation, while a duplicate label will remains on the product.  With variable data capabilities, specific, unique information regarding each device can also be printed onto each label.

Have a UDI Label Question? TLP can help!