Innovation in Medical Device - Are You ready for UDI? | Page 6

FDA Unique Device Identification (UDI) System

Develop Your Plan
The UDI changes are new, so leading practices are just emerging. Companies
should focus on assessing their individual situations and defining a plan based
on exposure and risk tolerance. Your plan of action depends on your company’s
situation and should be tailored to address gaps in your own level of readiness.
Plotting your readiness assessment across the various impact categories (as
illustrated below) helps companies understand and develop a personalized plan.

Impact Categories

Organization
Awareness
Readiness Level

High

Prepare to
adjust plans
based on
final ruling

Medium

Complete
your detailed
plans and
execute

Low

Accelerate
your efforts
to mobilize

Portfolio

Senior management
team aligned
on mandate

Majority of
products Class II
or exempt

GS1 or equivalent
standards
implemented

Majority of
products single
use or implants

Well integrated
master data
strategy with
good data integrity

UDI program
formed and
funded

Cross functional
engagement across
organizational units

Broad mix
of products

GS1 or equivalent
program in progress

Limited products
are multi-use
devices

PLM, Labeling
and Regulatory
Systems available

Segmented
efforts
proceeding

Siloed efforts
focused on
limited functions

High volume
of Class III
Products

Standards not
consistently
defined

Majority of
products subject
to direct marking

Limited systems,
dependent on
disparate sources
and personal stores

Preliminary
Scoping

Labeling

DM

Data & Implementation
Applications
Planning

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