Chapter 11: FDA Unique Device Identification Verification and Validation
170 Regulatory Affairs Professionals Society (RAPS)
correcting the information or providing adequate
justification to the agency as to why the informa-
tion is correct within 30 days of receiving FDA
notification. Labelers cannot ignore this notifica-
tion. Should a labeler not respond to THE FDA
within the 30 days post-notification, the agency
may either delete or correct the wrong infor-
mation. This FDA action does not relieve the
labeler from providing corrected information or
an explanation as to why the original information
is correct.
New DI Records
There are several reasons new DI records and
corresponding labels need to be implemented
using V&V, including:
• New device introduction
• Relabeling an existing device
• Changes to key GUDID attributes (see the
FDA’s Design control guidance for medical
device manufacturers)
Summary
UDI implementation is complex and requires
constant attention. Many company leaders
appear to be underestimating the impact UDI
will have on their organizations and the amount
of time it will take to implement and manage.
Top management must understand UDI is
here to stay and should commit the necessary
resources needed for successful implementa-
tion. The FDA will not be the only regulatory
authority to implement UDI. It will become a
worldwide standard.
Manufacturers that have implemented
unique identifiers have seen increased revenues
and decreased costs. Their hospital and GPO
customers view them as “easy” companies with
which to do business, resulting in a sales increase
for both contracted and noncontracted devices.
Hospitals need to implement systems that will
reduce their costs, and UDI is such a system. It
permits hospitals to manage their inventories
better by reducing or eliminating duplication and
providing improved inventory tracking. Barcodes
on products allow hospitals to charge patients
more accurately for the devices they use while
hospitalized. Manufacturers also have been able
to increase the speed to market for a new device
compliant with unique identification standards
by adding the device to existing GPO contracts.
This can increase the new device’s market expo-
sure very quickly.
Figure 11-2. GHTF Process Validation Decision Tree
Yes
No No
Yes Is Verification
Sufficient &
Cost Effective?
Is Process
Output Verifiable?
Validate
Redesign
Product and/or
Process
Verify &Control
the Process
170 Regulatory Affairs Professionals Society (RAPS)
correcting the information or providing adequate
justification to the agency as to why the informa-
tion is correct within 30 days of receiving FDA
notification. Labelers cannot ignore this notifica-
tion. Should a labeler not respond to THE FDA
within the 30 days post-notification, the agency
may either delete or correct the wrong infor-
mation. This FDA action does not relieve the
labeler from providing corrected information or
an explanation as to why the original information
is correct.
New DI Records
There are several reasons new DI records and
corresponding labels need to be implemented
using V&V, including:
• New device introduction
• Relabeling an existing device
• Changes to key GUDID attributes (see the
FDA’s Design control guidance for medical
device manufacturers)
Summary
UDI implementation is complex and requires
constant attention. Many company leaders
appear to be underestimating the impact UDI
will have on their organizations and the amount
of time it will take to implement and manage.
Top management must understand UDI is
here to stay and should commit the necessary
resources needed for successful implementa-
tion. The FDA will not be the only regulatory
authority to implement UDI. It will become a
worldwide standard.
Manufacturers that have implemented
unique identifiers have seen increased revenues
and decreased costs. Their hospital and GPO
customers view them as “easy” companies with
which to do business, resulting in a sales increase
for both contracted and noncontracted devices.
Hospitals need to implement systems that will
reduce their costs, and UDI is such a system. It
permits hospitals to manage their inventories
better by reducing or eliminating duplication and
providing improved inventory tracking. Barcodes
on products allow hospitals to charge patients
more accurately for the devices they use while
hospitalized. Manufacturers also have been able
to increase the speed to market for a new device
compliant with unique identification standards
by adding the device to existing GPO contracts.
This can increase the new device’s market expo-
sure very quickly.
Figure 11-2. GHTF Process Validation Decision Tree
Yes
No No
Yes Is Verification
Sufficient &
Cost Effective?
Is Process
Output Verifiable?
Validate
Redesign
Product and/or
Process
Verify &Control
the Process