Chapter 11: FDA Unique Device Identification Verification and Validation
162 Regulatory Affairs Professionals Society (RAPS)
What Does UDI Mean?
Critically, UDI serves two distinct but related
purposes, and it is important to address both
as part of the implementation. Firstly, UDI
adequately identifies a device throughout the
supply chain. Among many benefits, this helps
to control devices as they move through distribu-
tion, supports stock management, and facilitates
device recalls. Secondly, UDI is used to identify
devices as they are used on, or implanted in,
patients. The UDI is composed of two compo-
nents—a device identifier (DI) and one or more
production identifiers (PIs). The DI is a global
unique identifier specific to a particular device,
while PIs are a dynamic component and typically
include one or more of these:
• Lot number
• Serial number
• Manufacturing date
• Expiration date
Together, the DI and PI make up the UDI.
Who is Responsible for Applying the
UDI Label?
The FDA has identified the “labeler” as the per-
son responsible for applying the UDI label, not
necessarily the actual (physical) manufacturer of
the device (e.g., an original equipment manu-
facturer [OEM]). The labeler is defined as the
person who secures a label to a device and places
the device into commercial distribution with the
expectation that the label will not be replaced
or modified in any way. Further, a person who
replaces or substantially modifies the original
label and then places the device into commercial
distribution, with the expectation that the label
will not be replaced or modified in any way, is
also a labeler. Distributors who simply add their
name and address to the package are not consid-
ered labelers under this definition. Private-label
devices present a situation where the actual man-
ufacturer or the brand name holder can be the
labeler. This would be a business decision made
jointly by the manufacturer and brand-name
holder. The labeler also may be a specification
developer, single-use device reprocessor, conve-
nience kit assembler, repackager, or relabeler.
Is There a Required Date Format?
All human-readable dates (manufacturing date,
expiration date, etc.) printed on labels must
follow a YYYY-MM-DD format to harmonize
with international standard ISO 8601:2004. The
day is an absolute requirement. For example, 31
March 2025 must be presented as 2025-03-31.
This requirement applies to all medical device
classes that use dates on their labels, whether
they are subject to UDI or not.
Which “Day” Date Should be Used?
The FDA did not stipulate the “day” of the
month that a labeler should use on its device
labels. If a company currently uses a “day” on its
device, no change should be needed other than a
possible format change. If the company does not
use a “day,” it is suggested the same day be used
for all devices. Many companies use the last day
of the month. A word of caution: If a com-
pany stipulates a specific shelf life from date of
manufacture in the device submission, it may not
be able to use the last day of the month strategy
unless its clinical trials have proven the device
has an effective shelf life longer than the one
used on the labeling.
How Does a Company Obtain Labeler
Identification?
The FDA has accredited three agencies to oper-
ate systems to issue identifiers to device labelers:
• GS1
• Health Industry Business Communications
Council (HIBCC)
• International Council for Commonality in
Blood Bank Automation (ICCBBA)
GS1 and HIBCC are for medical devices, while
ICCBBA is for medical products of human
origin regulated as medical devices.
162 Regulatory Affairs Professionals Society (RAPS)
What Does UDI Mean?
Critically, UDI serves two distinct but related
purposes, and it is important to address both
as part of the implementation. Firstly, UDI
adequately identifies a device throughout the
supply chain. Among many benefits, this helps
to control devices as they move through distribu-
tion, supports stock management, and facilitates
device recalls. Secondly, UDI is used to identify
devices as they are used on, or implanted in,
patients. The UDI is composed of two compo-
nents—a device identifier (DI) and one or more
production identifiers (PIs). The DI is a global
unique identifier specific to a particular device,
while PIs are a dynamic component and typically
include one or more of these:
• Lot number
• Serial number
• Manufacturing date
• Expiration date
Together, the DI and PI make up the UDI.
Who is Responsible for Applying the
UDI Label?
The FDA has identified the “labeler” as the per-
son responsible for applying the UDI label, not
necessarily the actual (physical) manufacturer of
the device (e.g., an original equipment manu-
facturer [OEM]). The labeler is defined as the
person who secures a label to a device and places
the device into commercial distribution with the
expectation that the label will not be replaced
or modified in any way. Further, a person who
replaces or substantially modifies the original
label and then places the device into commercial
distribution, with the expectation that the label
will not be replaced or modified in any way, is
also a labeler. Distributors who simply add their
name and address to the package are not consid-
ered labelers under this definition. Private-label
devices present a situation where the actual man-
ufacturer or the brand name holder can be the
labeler. This would be a business decision made
jointly by the manufacturer and brand-name
holder. The labeler also may be a specification
developer, single-use device reprocessor, conve-
nience kit assembler, repackager, or relabeler.
Is There a Required Date Format?
All human-readable dates (manufacturing date,
expiration date, etc.) printed on labels must
follow a YYYY-MM-DD format to harmonize
with international standard ISO 8601:2004. The
day is an absolute requirement. For example, 31
March 2025 must be presented as 2025-03-31.
This requirement applies to all medical device
classes that use dates on their labels, whether
they are subject to UDI or not.
Which “Day” Date Should be Used?
The FDA did not stipulate the “day” of the
month that a labeler should use on its device
labels. If a company currently uses a “day” on its
device, no change should be needed other than a
possible format change. If the company does not
use a “day,” it is suggested the same day be used
for all devices. Many companies use the last day
of the month. A word of caution: If a com-
pany stipulates a specific shelf life from date of
manufacture in the device submission, it may not
be able to use the last day of the month strategy
unless its clinical trials have proven the device
has an effective shelf life longer than the one
used on the labeling.
How Does a Company Obtain Labeler
Identification?
The FDA has accredited three agencies to oper-
ate systems to issue identifiers to device labelers:
• GS1
• Health Industry Business Communications
Council (HIBCC)
• International Council for Commonality in
Blood Bank Automation (ICCBBA)
GS1 and HIBCC are for medical devices, while
ICCBBA is for medical products of human
origin regulated as medical devices.