The Medical Device Validation Handbook
163
What Additional Information Must be
Printed on the Device Label?
Medical devices must follow the labeling
requirements detailed in 21 CFR Part 8015 in
addition to the new requirements per the UDI
rule. Specifically, the regulation requires a UDI
(DI plus PI) to be printed in easy-to-read plain
text, and in automatic identification and data
capture (AIDC) format on the device label. The
AIDC format is dictated by the issuing agency.
Information printed on labels also is dictated by
other governmental bodies, such as the European
Commission. A company may need to seek
approval of any label changes from these other
bodies, particularly if the changes are major.
Does UDI Impact Existing SOPs?
The FDA expects any standard operating pro-
cedure (SOP) changes made by a labeler to be
compliant with the UDI regulation. The agency
also expects labelers to treat UDI the same as any
other Quality System Regulation (QSR) aspect.6
Table 11-1 shows the sections of the QSR and
related regulations that were modified to include
UDI requirements—from labeling to recalls, to
postmarket surveillance plans. As part of the
implementation plan, the labeler will need to
include SOP updating as a key milestone.
How Should Data be Submitted to
the GUDID?
There are two standard-based methods to submit
data to the GUDID—structured input via
an FDA web interface or the Health Level 7
Structured Product Labeling (HL7 SPL) pro-
cess. HL7 SPL is an extensible markup language
(XML) format and uses the FDA’s Electronic
Submissions Gateway (ESG) as the pathway
for inputting data into GUDID. To submit
data to GUDID, a company must first request a
GUDID user account from the FDA. Data are
submitted one record at a time for both methods.
There is no batch process.3,4
What is GMDN?
Global Medical Device Nomenclature is an
international naming system for medical devices.
For GUDID, a GMDN Preferred Term (PT)
Table 11-1. UDI Impact on Existing Regulations
Part Subpart Section(s) Conforming Amendments
801-Labeling A §801.18 (a)(b) New date format YYYY-MM-DD
B New section Adds labeling requirements for UDI
803-Med. Dev. Reporting C §803.32, §803.33
§803.42 §803.53
Adds UDI as requirement
806-Corrections &
Removals
B §806.10 §806.20 Adds UDI as requirement
810-Med. Dev. Recall B §810.10 Adds UDI as requirement
814-Premarket App. E §814.84 Adds UDI as requirement
820-Quality System K §820.120 Labeling inspection—added requirement to inspect UDI
M §820.184 Requires adding UDI or UPC to record
M §820.198 Requires including UDI or UPC in investigation report
M §820.200 Requires including UDI or UPC in service report
821-Tracing
Requirements
B §821.25 UDI to be provided to FDA when requested (single/
multi-patient use)
C §821.30 Adds UDI as requirement
822-Postmarket
Surveillance
C §822.9 Adds DI to information to be provided
163
What Additional Information Must be
Printed on the Device Label?
Medical devices must follow the labeling
requirements detailed in 21 CFR Part 8015 in
addition to the new requirements per the UDI
rule. Specifically, the regulation requires a UDI
(DI plus PI) to be printed in easy-to-read plain
text, and in automatic identification and data
capture (AIDC) format on the device label. The
AIDC format is dictated by the issuing agency.
Information printed on labels also is dictated by
other governmental bodies, such as the European
Commission. A company may need to seek
approval of any label changes from these other
bodies, particularly if the changes are major.
Does UDI Impact Existing SOPs?
The FDA expects any standard operating pro-
cedure (SOP) changes made by a labeler to be
compliant with the UDI regulation. The agency
also expects labelers to treat UDI the same as any
other Quality System Regulation (QSR) aspect.6
Table 11-1 shows the sections of the QSR and
related regulations that were modified to include
UDI requirements—from labeling to recalls, to
postmarket surveillance plans. As part of the
implementation plan, the labeler will need to
include SOP updating as a key milestone.
How Should Data be Submitted to
the GUDID?
There are two standard-based methods to submit
data to the GUDID—structured input via
an FDA web interface or the Health Level 7
Structured Product Labeling (HL7 SPL) pro-
cess. HL7 SPL is an extensible markup language
(XML) format and uses the FDA’s Electronic
Submissions Gateway (ESG) as the pathway
for inputting data into GUDID. To submit
data to GUDID, a company must first request a
GUDID user account from the FDA. Data are
submitted one record at a time for both methods.
There is no batch process.3,4
What is GMDN?
Global Medical Device Nomenclature is an
international naming system for medical devices.
For GUDID, a GMDN Preferred Term (PT)
Table 11-1. UDI Impact on Existing Regulations
Part Subpart Section(s) Conforming Amendments
801-Labeling A §801.18 (a)(b) New date format YYYY-MM-DD
B New section Adds labeling requirements for UDI
803-Med. Dev. Reporting C §803.32, §803.33
§803.42 §803.53
Adds UDI as requirement
806-Corrections &
Removals
B §806.10 §806.20 Adds UDI as requirement
810-Med. Dev. Recall B §810.10 Adds UDI as requirement
814-Premarket App. E §814.84 Adds UDI as requirement
820-Quality System K §820.120 Labeling inspection—added requirement to inspect UDI
M §820.184 Requires adding UDI or UPC to record
M §820.198 Requires including UDI or UPC in investigation report
M §820.200 Requires including UDI or UPC in service report
821-Tracing
Requirements
B §821.25 UDI to be provided to FDA when requested (single/
multi-patient use)
C §821.30 Adds UDI as requirement
822-Postmarket
Surveillance
C §822.9 Adds DI to information to be provided