Postmarket Requirements for Medical Devices: A Practical Guide
43
Labeling Requirements for Unique
Device Identification
The following requirements briefly outline the
UDI compliance process:
• Under 21 CFR 801.45,49 if a device is a
reusable device and intended to be repro-
cessed before each use, the UDI should be
permanently marked on the device itself.
This rule is not applicable if a reusable device
intended to be reprocessed before each use
meets any of the following listed criteria:
o Any type of direct marking on the
device that would interfere with the
device’s safety or effectiveness
º It is not technologically feasible to put a
direct mark on the device
º The device is approved or cleared for
single use only
º The device is already directly marked
with the UDI on the device
• Stand-alone software devices are required
to follow the same general UDI labeling
requirement as any other medical devices.
There is no special requirement for stand-
alone software per 21 CFR 801.50
• If a device label includes a printed expira-
tion date, date of manufacture, or any other
required date, the dates should be in stan-
dard format YYYY-DD-MM, consistent
with international standards and practice
Combination products and electronic
radiation-emitting are exempted from this
regulation (21 CFR 801.18).50
Global Unique Device Identification
Database
On 27 June 2014, FDA issued the Global
Unique Device Identification Database
(GUDID) guidance,51 which outlines the infor-
mation a device labeler is required to submit
to the FDA GUDID database. The GUDID
database is an online repository of device iden-
tification (DI) information, available for public
search, retrieval, and use. Production Information
(PI) is not submitted to the GUDID, although
the DI record can indicate which PI attributes
are on the device label, unless excepted. The
GUDID must include all the data elements
required by 21 CFR 830.310.52
Additionally, this guidance was instrumental
in defining how to compile and submit device
information within a database. UDI data can be
submitted to the database using the following
two options:
1. Manual entry into the database using
GUDID web application
2. Health Level Seven (HL7) Structured
Product Labeling (SPL) submission via the
FDA ESG pathway
The steps for submitting UDI data to the
GUDID database are summarized in Figure 2-8.
FDA may deny or eliminate the submitted
DI information in any of the following scenarios,
as per 21 CFR 830.300:
• If it does not conform to requirements in 21
CFR 830.20
• If the device has not been manufactured in
the US
Figure 2-7. Unique Device Identification System: Three Distinct Concepts
1. Development of a standardized Unique Device Identification (UDI) system
2. Placing UDI in human readable form and machine-readable form using AIDC technology
3. GUDID-FDA database for registering UDI data
43
Labeling Requirements for Unique
Device Identification
The following requirements briefly outline the
UDI compliance process:
• Under 21 CFR 801.45,49 if a device is a
reusable device and intended to be repro-
cessed before each use, the UDI should be
permanently marked on the device itself.
This rule is not applicable if a reusable device
intended to be reprocessed before each use
meets any of the following listed criteria:
o Any type of direct marking on the
device that would interfere with the
device’s safety or effectiveness
º It is not technologically feasible to put a
direct mark on the device
º The device is approved or cleared for
single use only
º The device is already directly marked
with the UDI on the device
• Stand-alone software devices are required
to follow the same general UDI labeling
requirement as any other medical devices.
There is no special requirement for stand-
alone software per 21 CFR 801.50
• If a device label includes a printed expira-
tion date, date of manufacture, or any other
required date, the dates should be in stan-
dard format YYYY-DD-MM, consistent
with international standards and practice
Combination products and electronic
radiation-emitting are exempted from this
regulation (21 CFR 801.18).50
Global Unique Device Identification
Database
On 27 June 2014, FDA issued the Global
Unique Device Identification Database
(GUDID) guidance,51 which outlines the infor-
mation a device labeler is required to submit
to the FDA GUDID database. The GUDID
database is an online repository of device iden-
tification (DI) information, available for public
search, retrieval, and use. Production Information
(PI) is not submitted to the GUDID, although
the DI record can indicate which PI attributes
are on the device label, unless excepted. The
GUDID must include all the data elements
required by 21 CFR 830.310.52
Additionally, this guidance was instrumental
in defining how to compile and submit device
information within a database. UDI data can be
submitted to the database using the following
two options:
1. Manual entry into the database using
GUDID web application
2. Health Level Seven (HL7) Structured
Product Labeling (SPL) submission via the
FDA ESG pathway
The steps for submitting UDI data to the
GUDID database are summarized in Figure 2-8.
FDA may deny or eliminate the submitted
DI information in any of the following scenarios,
as per 21 CFR 830.300:
• If it does not conform to requirements in 21
CFR 830.20
• If the device has not been manufactured in
the US
Figure 2-7. Unique Device Identification System: Three Distinct Concepts
1. Development of a standardized Unique Device Identification (UDI) system
2. Placing UDI in human readable form and machine-readable form using AIDC technology
3. GUDID-FDA database for registering UDI data