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Unique Device Identification (UDI): Which Medical Devices Will Require the Mark and When?

Posted on May 7, 2014 · Posted in FDA Regulatory Updates

Consumer products have been using UPC identifier codes for years. This simple measure has greatly improved consumer product safety and supply chain efficiency. Finally, the medical device industry and the FDA are in the last stages of implementing a sophisticated device tracking system.

Information presented is based on official FDA guidance documentation.

The UDI System Advantages:

· Traceability of information related to adverse events, product functionality and raw material problems.

· The FDA, medical facilities and distributors can identify product problems more quickly, better target recalls and improve patient safety.

· A global tracking system designed to secure distribution & supply chains, helping to combat counterfeiting and prepare for medical emergencies.

The UDI is a unique numeric or alphanumeric code that includes a device identifier, which is specific to a device model, and a manufacturing ID, which includes the current production information for that device: such as the lot or batch number, the serial number and/or expiration date.

The FDA is creating a database that will include a standard set of basic identifying elements for each UDI. Most of the information will be available to the public so that users of a medical device can easily reference information about the device. The FDA will not provide private patient information in the database.

The FDA developed chart below will help you plan for changes to your manufacturing, labeling and packing requirements related to the new UDI rules.

1 year after 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 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 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 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 label and package of class I medical devices and devices that haven’t been classified into class I, class II, or class III must bear a UDI.

-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 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.

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