UDI Regulatory Overview

Slide 1

Hello, my name is Linda Sigg, and I am the Associate Director of 

Informatics for CDRH. I lead the team that implements the Unique Device 

Identification, or UDI program, and today I will provide a regulatory 

overview of the UDI system.

Slide 2

The Learning Objectives of this session are to:

Recognize the four steps of the UDI System,

Understand the labeler requirements,

Know the UDI compliance dates, and

Identify some of the UDI adoption benefits

Slide 3

What is the UDI System and why do we need it? Congress directed the 

FDA to establish a UDI system to adequately identify medical devices 

through distribution and use, with the goal to realize many important public 

health benefits. 

The UDI system was signed into law in 2007, as part of the Food and Drug 

Administration Amendments Act. The FDA Safety and Innovation Act was 

signed into law in 2012, and required FDA to impose specific compliance 

time frames for certain devices. FDA published the final UDI Rule on 

September 24, 2013.

Slide 4

The UDI system's objective is to enable medical devices to be identified 

through distribution and use, with specific goals:

Facilitate the rapid and accurate identification of a device and prevent 

incorrect identification.

Enable access to important information concerning the device such as the 

company name, brand name, description and important safety information

And provide a standard and clear way to document device use in electronic 

health records, clinical information systems, claims data sources and 

registries
Slide 5

The UDI Program is essentially a four step process. 

First, the FDA built the regulatory and technical framework for the UDI 

System in the final rule that was published on September 24, 2013.

Slide 6

Next, the medical device industry needs to comply. A UDI is required on 

device labels and device packages, and in some cases on the devices 

themselves, unless there is an exception or alternative granted by the FDA.

Slide 7

Then, additional data about each device is required to be submitted to the 

Global UDI Database, which we call the GUDID for short. The GUDID 

serves as the repository of key device identification information.

Slide 8

Finally, the success of the UDI system depends upon adoption and 

implementation of the UDI System by the health care community. 

Step one, the standardized system, has been established. 

Today's discussion will focus mainly on Steps two and three and the 

labeler's responsibilities. 

And for the last step, I will briefly describe several of the UDI benefits at the 

end of this presentation. These benefits can only be realized through 

successful adoption and implementation of the UDI system.

Slide 9

As part of the UDI system, a UDI is required on device labels. What is a 

device Label? Section 321(k) of the Food, Drug, and Cosmetic Act defines 

"label" as a display of written, printed, or graphic matter upon the 

immediate container of any article. For retail devices, the UDI is required to 

appear on the outside container or wrapper of the retail package or be 

easily legible through the outside container or wrapper. This means the UDI 

can be on the retail package and the package can be enclosed in a clear 

container or wrap.

Slide 10

What is the UDI? It is a unique string of characters on a device label, 

package or in some instances on the device itself. It is both in human 

readable plain text and machine readable formats. Here are some 

examples of the Automatic Identification and Data Capture, or AIDC, 

machine readable formats, including the 1D barcode that is on the label, 
the 2D barcode that is to the left of the label, and the symbol at the bottom 

left, which is an abstract of Radio Frequency Identification, or RFID, 

technology. All are acceptable machine readable formats for UDI 

purposes, and for this presentation, I will use the 1D barcode for the 

examples. 

If you go back to the 1D barcode, the numbers below the bar code are the 

human readable plain text form of the UDI. The UDI is composed of the 

Device Identifier, or DI, and the Production Identifiers, or PI. The DI is the 

yellow portion of the plain text on the left, and the PI is the green portion of 

the plain text on the right.

Slide 11

Now let's parse the different parts of the UDI. The DI is the mandatory, 

fixed portion of a UDI that identifies the labeler and the specific version or 

model of a device. Once the DI is assigned to a specific version or model 

of a device, the DI never changes. If a different version or model is made 

available, a new DI is required. The DI serves as the primary key used to 

look up information about the device in the GUDID. Only one labeler can 

be associated with each DI.

Slide 12

The PI is the variable portion of the UDI. Except for Class 1 devices, when 

certain information is on the label it should be in the UDI as well. This 

information includes lot, batch, serial number, expiration date, date of 

manufacture, and for human cell and tissue products, or HCT/P's regulated 

as devices, the distinct identification code. This data will change for each 

lot or batch, or in the case of some devices like implantables, for each 

serialized device.

Slide 13

The UDI regulations define device package as a package that contains a 

fixed quantity of a particular version or model of a device. Each package 

level requires a different UDI.

Slide 14

Here is an example of package levels.

Slide 15

The base package is the lowest level of a device package containing a full 

UDI. In this example, the base package is a single wrapped catheter. The 

UDI is on the individual device wrapper and the base package DI is 1001.

Slide 16
The individually wrapped catheters are packaged in a box of thirty. That 

box of thirty is related to the base package and is the next package level 

that requires a different DI -2001.

Slide 17

If the catheters are also packaged in boxes of fifty, that would also be a 

next package level with a DI that is different from the DI on the box of thirty 

but still related to the base package DI - 2002.

Slide 18

Multiple boxes can also be packaged together in a case, a third package 

level. If boxes of thirty catheters are packaged twelve to a case, that case 

is a third package level requiring a new DI, but again related to the base DI -

3001.

Slide 19

Here are examples of what are not considered packages and do not require 

a UDI. Any type of wrapping intended to protect the device from damage 

during shipping. As seen in the picture on the left, this includes inner 

linings, bubble wrap, and other protective material. The middle picture is a 

pallet. Pallets are another example of a package that does not require a 

UDI, especially when the number of units differs from pallet to pallet. In the 

picture on the right, any shipping containers used to transport devices 

when the contents vary from one shipment to another do not require a UDI.

Slide 20

Let's talk about Direct Marking. In addition to including the UDI on the label 

and package, the UDI needs to be directly marked on the device itself if the 

device is intended to be used more than once and intended to be 

reprocessed between uses. This permanent UDI may be in plain text, AIDC 

technology, or both. The direct mark UDI may be identical to the UDI on the 

label or it may be different to distinguish the packaged device from the 

unpackaged device.

Slide 21

What is a Labeler? The labeler is responsible for compliance with the UDI 

requirements. The UDI rule created the term "Labeler", and in 21 CFR 801.3 

the labeler is defined as the one who causes a label to be applied to a 

device, or who causes the label to be replaced or modified, with the intent 

that the device will be introduced into interstate commerce without any 

subsequent replacement or modification of the label.

Slide 22

A device manufacturer is usually the labeler, but not always. The term 

labeler can include contract manufacturers, private label distributors and 
convenience kit assemblers, as well as device repackagers or device 

relabelers. However, distributors who only have their name and contact 

information added to an existing label may not be considered labelers.

Slide 23

At this point, we have covered the UDI and the DI and PI portions of the 

UDI. In addition, we have talked about the labels, packages, and who are 

the labelers. Now, let's discuss how UDIs are created.

Slide 24

The UDI rule requires all UDIs to be issued under a system operated by an 

FDA-accredited Issuing Agency. The Rule also requires the Issuing 

Agencies to create systems that conform to international standards.

Slide 25

The FDA has accredited several Issuing Agencies, and labelers are 

required to work with at least one accredited Issuing Agency. For more 

information on how to build your UDIs, first make sure you understand the 

basic UDI requirements, and then follow the guidelines and use the tools 

provided by the Issuing Agency. The list of FDA-accredited Issuing 

Agencies is available on the FDA website.

Slide 26

To bring date formats in line with international standards, dates on the 

label intended to be brought to the attention of the user, such as expiration 

date and date of manufacture, must be in a specified format to harmonize 

with international standards. This format starts with four digits for the 

year, followed by two digits for the month, and then two digits for the day, 

separated by hyphens. For example, January 30, 2014 will be written as 

2014 hyphen 01 hyphen 30. The date format compliance date is the same 

as the compliance date for the UDI.

Slide 27

Let's review the basic UDI requirements. We just covered that a UDI is 

required on every device label and device package, and in some cases on 

the device itself, unless there is an exception or alternative granted by 

FDA. Next, we will talk about the key information that must be submitted to 

the Global UDI Database, or the GUDID.

Slide 28

The GUDID serves as the repository of key device identification 

information. The GUDID contains only the Device Identifier, or DI, which 

serves as the primary key to obtain device information in the database. 

Production Identifiers, or PIs, are not submitted to nor stored in the GUDID. 

The GUDID contains only production identifier flags to indicate which PIs 

are in the device UDI. The GUDID does not contain any patient identifying 
information. There is much more information on our FDA UDI website, and 

there are modules that explain the GUDID data submission process in 

detail.

Slide 29

Can anyone see the data that is submitted to the GUDID? The answer is a 

qualified yes. One of the key objectives of the UDI system is to enable 

health care professionals and others to more rapidly and precisely identify 

a device and obtain important information concerning the characteristics of 

the device. Therefore, once the labeler has verified their data, most data 

from the GUDID is made public via AccessGUDID. AccessGUDID launched 

in May 2015 through a partnership with the National Library of Medicine. 

The main features of AccessGUDID are the public search capability, the 

database download capability and the web services. Please check the site 

often, as new features and functionality are being added to improve 

AccessGUDID.

Slide 30

To give everyone enough time to prepare and ensure orderly compliance 

with the regulation, the compliance dates for UDI requirements are phased 

in over a seven year period based primarily on the device classification 

with the compliance dates for higher risk devices occurring first. Here are 

the key compliance dates. There are more details on compliance dates on 

the UDI website which you can access using the link on this slide.

Slide 31

All medical devices must be in compliance with the requirements of the UDI 

Rule by the applicable compliance dates, unless an exception or alternative 

has been granted by the FDA. Some key general exceptions include Class 

1 devices that are exempt from current Good Manufacturing Practices, or 

cGMP, individual single use devices of a single version or model that are 

sold and intended to be stored within a single device package until 

removed for use, devices under premarket investigation or intended solely 

for nonclinical use, devices intended for export from the US, and individual 

devices in a convenience kit. In addition, a device packaged and labeled 

for sale prior to its compliance date is excepted from UDI requirements for 

three years after the compliance date. This is not an exhaustive list of the 

general exceptions. All the general exceptions are listed in 21 CFR 801.30.

Slide 32

There is also a provision that allows FDA to grant individual exceptions or 

alternatives. FDA may grant exceptions or alternatives either on its own 

initiative or in response to a request from a labeler. Labelers submit such 

requests to the UDI Help Desk. 
Slide 33

If you recall from the four steps of the UDI system, the last step is adoption. 

The UDI will clearly and unambiguously identify the device. The availability 

of the UDI in electronic health information allows connections to different 

sources of data to easily link information that was once difficult or 

impossible to link. With the UDI, there is now a key that unlocks the data. 

A specific version or model of a device could be linked to an adverse event, 

or to a recall. And better data means better analysis of the data for faster 

and more accurate reporting and decisions.

Slide 34

With the UDI as the unique key, and electronically available on devices, 

device data for patient care can be rapidly and accurately captured and 

retrieved. The GUDID contains several device safety fields that help 

providers at the point of care. And once the UDI is available, patient safety 

could be improved by tracking the device through the supply chain to the 

point of use and beyond. For example, if the UDI is on the device and the 

UDI is in the EHR then recalls can be connected to patients.

Slide 35

FDA is working with several different partners to ensure the UDI is in 

Electronic Health Records, Claims, and Registries. FDA also works with 

standards organizations to ensure there is interoperability between the 

data sets so that the data can be linked and integrated in systems.

With more specific device information it is possible to improve patient 

safety, identify poor performers in the marketplace and facilitate device 

innovation. UDI is one of the cornerstones of National Medical Device 

Evaluation System, and adoption is necessary to reap the benefits.

Slide 36

I hope you found the information presented very informative. Remember, 

there are four steps to the UDI system, and steps two and three are the 

labeler requirements for labels and data submission. I would like to 

encourage labelers to be aware of your compliance dates, and please start 

the label and data submission processes early to ensure your requirements 

are met prior to the compliance date. If you would like more information 

about the UDI benefits, there are several listed in the preamble of the UDI 

Rule. Thank you for your time today, if you have any questions about UDI 

you can access information on our website at www.fda.gov/udi

Slide 37

This presentation and other helpful videos and educational resources can 

be found at CDRH Learn. For text based information on premarket and 

post market topics including how to bring a medical device to market 

please visit device advice. For additional information on these or any other 
medical device regulatory topics feel free to contact the Division of 

Industry and Consumer Education.

Thank you!