Innovation in Medical Device - Are You ready for UDI? | Page 4

Complying with UDI requires your organization to fully understand the
nuances of the FDA regulations and how they will impact your organization.
As you prepare to define your organization’s approach to implementing
UDI, key factors and questions to consider include:

1

Our Regulatory
Affairs, Research &
Development and
Supply Chain functions
are all impacted.

3

Who will champion this
in our organization?

2

Barcoding and
labeling are not
standardized across our
manufacturing facilities.

5

Does directly marking
multi-use products add
complexity to my design inputs
and development plans?

Will it complicate manufacturing
and execution systems?

Where will the budget to
implement be allocated?
How do we use UDI
to drive added benefit
across our enterprise?

Our products are
highly engineered.

What will be the impact
on time to market?

4

Which barcoding standards
are best for our needs?
Without common labeling
systems, how do we
efficiently move to a
common label format?
What is the impact to our
operations (e.g. Manufacturing,
Warehousing and Logistics)?

Our data and information
is dispersed across many
diverse “systems” including
desktops, file shares and
enterprise-wide systems.
What data are really required
to satisfy the requirements?
Can we locate it and is it in
an electronic data format?
Is it complete and accurate?

6

FDA’s UDI requirements
will likely evolve;
international regulatory
bodies will create their
own requirements

FDA Unique Device Identification (UDI) System

Think You’re Ready?
Key Considerations

How will we keep track of
changing requirements?
How will we interact with
regulatory agencies to
understand the evolving
requirements?
How can we build our systems
to flexibly accommodate
future requirements?

Our UDI plans are
not developed.
How long will it take to scope,
plan and implement?
Can we be ready in time?
What is our contingency plan?

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