Section I: North America: United States and Canada
Chapter 2: Postmarket Compliance: US
42
An example of a UDI is presented in Figure 2-6.
The UDI rule47 was passed by FDA on 24
September 2013 and became effective on 23
December 2013. Its provisions offer methods
for the identification of medical devices sold in
the US, from manufacturing and distribution to
patient use therefore, UDI enhances the effec-
tiveness of postmarket safety-related activities
for devices. The lack of UDI hinders the identi-
fication of devices throughout their distribution
and use, the reporting and analysis of AE data,
and the timely removal of recalled devices from
use. Regulations under 21 CFR 830.2048 require
UDIs to meet the following requirements:48
• UDI must be issued by FDA or FDA-
accredited agencies such as the Global
Language of Business GS1, Health Industry
Business Communications Council
(HIBCC), and International Council
for Commonality in Blood Banking
Automation (ICCBBA)
• It should conform to the following listed
international standards:
º ISO/IEC 15459-2 :Information
Technology—Unique Identifiers—Part
2: Registration Procedures
º ISO/IEC 15459-4 :Information
Technology—Unique Identifiers—Part
4: Individual Items
º ISO/IEC 15459-6 :Information
Technology—Unique Identifiers—
Part 6: Unique Identifier for Product
Groupings
• The UDI should only use numbers and
characters from the invariant character set of
ISO/IEC 646: Information Technology—
ISO bit-coded character set for information
technology
In addition, this rule requires the label and
package of medical devices to include a UDI
meeting the requirements in 21 CFR 801.20
and 830. This rule provides general exceptions
or alternative placements. The “device labeler”
is responsible for complying with the UDI
label requirement, data submission, and record
provisions. The UDI should be provided as
a plain-text (human readable form) and in a
machine-readable form that uses automatic iden-
tification and data capture (AIDC) technology48
(See Figure 2-7).
Figure 2-6. UDI Example
Chapter 2: Postmarket Compliance: US
42
An example of a UDI is presented in Figure 2-6.
The UDI rule47 was passed by FDA on 24
September 2013 and became effective on 23
December 2013. Its provisions offer methods
for the identification of medical devices sold in
the US, from manufacturing and distribution to
patient use therefore, UDI enhances the effec-
tiveness of postmarket safety-related activities
for devices. The lack of UDI hinders the identi-
fication of devices throughout their distribution
and use, the reporting and analysis of AE data,
and the timely removal of recalled devices from
use. Regulations under 21 CFR 830.2048 require
UDIs to meet the following requirements:48
• UDI must be issued by FDA or FDA-
accredited agencies such as the Global
Language of Business GS1, Health Industry
Business Communications Council
(HIBCC), and International Council
for Commonality in Blood Banking
Automation (ICCBBA)
• It should conform to the following listed
international standards:
º ISO/IEC 15459-2 :Information
Technology—Unique Identifiers—Part
2: Registration Procedures
º ISO/IEC 15459-4 :Information
Technology—Unique Identifiers—Part
4: Individual Items
º ISO/IEC 15459-6 :Information
Technology—Unique Identifiers—
Part 6: Unique Identifier for Product
Groupings
• The UDI should only use numbers and
characters from the invariant character set of
ISO/IEC 646: Information Technology—
ISO bit-coded character set for information
technology
In addition, this rule requires the label and
package of medical devices to include a UDI
meeting the requirements in 21 CFR 801.20
and 830. This rule provides general exceptions
or alternative placements. The “device labeler”
is responsible for complying with the UDI
label requirement, data submission, and record
provisions. The UDI should be provided as
a plain-text (human readable form) and in a
machine-readable form that uses automatic iden-
tification and data capture (AIDC) technology48
(See Figure 2-7).
Figure 2-6. UDI Example