FREYR UDI VISION SERIES SESSION 1 - UDI READINESS

Agenda
1. Overview - UDI
2. GUDID Components
3. UDI – Master Data Management
4. Freyr Leverage – UDI Compliance Expertise
5. Freyr IDENTITY – UDI Software Solution
6. Freyr Corporate Overview
7. Q&A

OVERVIEW
UNIQUE DEVICE IDENTIFICATION
Presenter : Alan

FDA UDI Rule Summary
The Food and Drug Administration (FDA) has released a final rule (September, 2013) requiring that most medical
devices distributed in the United States carry a unique device identifier, or UDI.
The UDI ruling implementation timelines are based on the product classification emphasizing on risks. Class III
devices will be first to comply, then Class II, and concluding with Class I.
As part of the UDI system, FDA has created a Global Unique Device Identification Database (GUDID) which will
include a standard set of basic identifying elements for each device with a UDI.
The GUDID is made available to the public and serves as a centralized repository for easy device information look up.
What is UDI
A UDI consists of two parts; Device Identifier (DI) + Production Identifier (PI), i.e. UDI = DI+PI. A DI is mandatory,
fixed portion of a UDI that identifies the device information. PI is a conditional, variable portion of a UDI that
identifies specific attributes of a device when included on the label.
UDIs are issued by an FDA accredited issuing agency that operates a system for assignment of UDIs according to the
final rule.

Impact to the Medical Device Industry
CHALLENGES BENEFITS
 Collection, Conversion and Submission of UDI data to
GUDID.
 Timely review and approval of all UDI data through
auditing internal processes.
 Create new submissions for all product versions and
variants.
 Update submissions for changed products.
 Track FDA responses, including approvals, rejections,
product recalls, etc.
 Developing recordkeeping and reporting policies and
procedures.
 Comply with similar global UDI regulations coming soon
from various regional markets.
 Effective medical device recalls.
 Enhanced patient safety.
 Adequate tracking and tracing.
 Accurate reporting of adverse event reports.
 More transparency in supply chain and inventory
management.
 Improved post-market surveillance.
 Single source of information for public and health
professionals.
 Device documentation for use in EHRs, clinical information
systems, and registries, etc.
 Enhanced business processes.

Issuing Agencies
Under the GS1, the Global Trade Item Number™ (GTIN™) is used for the unique identification of
trade items worldwide.
A device identifier with GS1 as issuing agency shall be greater than 12 digits or equal to 14 digits in
length; DIs with less than 14 digits should be appended with leading zeros.
Brand Owners or manufacturers must allocate and maintain their GTINs according to the rules of the
FDA UDI mandate and the GS1 Standard.
A device identifier with ICCBBA as issuing agency shall be alphanumeric; 10 or 16 characters in length.
ISBT 128 is the global standard for the terminology, identification, labeling, and information transfer
of medical products of human origin (including blood, cell, tissue, and organ products) across
international borders and disparate health care systems.
HIBCC codes are alphanumeric and up to 6-23 characters in length..
Labeler identification Code (LIC) is assigned by HIBCC. Identifies the labeler. It is four alphanumeric
characters.

Timelines in Detail
Sept 24, 2014
 Class III devices, including class III stand alone software
 Devices licensed under the PHS Act
 Implantable, life-supporting and life-sustaining
(I/LS/LS) devices, including stand alone software
 Direct Marking of I/LS/LS for certain intended uses
 Class II devices
 Direct Marking for class III devices and devices licensed
under the PHS Act, for certain intended uses
 Class I devices and devices not classified class I, II or III
 Direct Marking of class II devices for certain intended
uses
Sept 24, 2015
Sept 24, 2016
Sept 24, 2018
Sept 24, 2020
 Direct Marking of class I devices and devices not
classified into class I, II or III, for certain intended
uses

GUDID
COMPONENTS
Presenter : Prasanna

GUDID Components
Centralized repository of key device identification information. Contains only the DI information; PI information is
not submitted or stored in the GUDID.
Contains only PI Yes/No flags to indicate which PI attribute(s) are present on the device label. GUDID account user
information is not made public.
Device attribute information can be submitted through two ways:
1. GUDID FDA Interface 2. HL7 SPL submission
A GUDID account is required regardless of the submission method chosen by the labeler.
FDA GUDID Interface : Manual data capture, one record submission at a time.
HL7 SPL : Create and submit fully valid SPLs through ESG, Submission of device information as xml files – one
record at a time. Should complete ESG account establishment and testing process.
Labeler : Responsible to submit the device information to GUDID.
Third Party : A Labeler can authorize a third party to submit the device data on the labeler’s behalf.

Steps for GUDID Compliance
Class III device manufacturers who applied for a year extension and Class II companies should gear up well
ahead of time in creating GUDID accounts.
The sense of urgency being, it takes time for FDA to process numerous requests pouring in for GUDID
production accounts.
Firstly, a test account will be provided where a labeler has to execute all the possible test submission
scenarios successfully and after proper review a production account would be issued. This whole process
is time consuming.
Once a request is
raised FDA will send
an application for
GUDID production
account
After receiving the
completed application
GUDID will activate
the test account
The labeler has to
execute all the
possible test scenarios
for their devices
GUDID will activate the
production account after
reviewing the test
scenarios.

GUDID Data Attributes
Device Identifier Information
→ Issuing Agency
→ Primary DI Number
→ Device Count
→ Unit of Use DI Number
→ Labeler DUNS Number
→ Company Name
→ Company Physical Address
→ Brand Name
→ Version or Model Number
→ Catalog Number
→ Device Description
Commercial Distribution
→ DI Record Publish Date
→ Commercial Distribution End
Date
→ Commercial Distribution Status
Secondary DI
→ Secondary DI Issuing Agency
→ Secondary DI Number
Package DI
→ Package DI Number
→ Quantity per Package
→ Contains DI Package
→ Package Type
→ Package Discontinue Date
→ Package Status
Customer Contact
→ Customer Contact Phone
→ Customer Contact Email
Direct Marking
→ Device subject to Direct Marking
but exempt
→ DM DI different from Primary DI
→ DM DI Number
Device Status
→ (HCT/P)
→ Kit
→ Combination Product
FDA Product Code
→ Product Code
→ Product Code Name
FDA Listing
→ FDA Listing Number
Premarket
→ Device Exempt from Premarket
Submission
→ FDA premarket Submission Number
→ Supplement Number
GMDN/FDA PT
→ Code
Device Characteristics
→ For Single-Use
Production Identifiers on Label
→ Lot/Batch Number
→ Manufacturing Date
→ Expiry Date
→ Serial Number
→ Donation Identification Number
Latex Information
→ Device required to be labeled as
containing natural rubber latex or
dry natural rubber (21 CFR 801.437)
→ Device labeled as “not made with
natural rubber latex”
Prescription Status
→ Prescription Use (Rx)
→ Over The Counter (OTC)
MRI Safety Status
→ What MRI safety information does
labeling contain?
Clinically Relevant Size
→ Size Type
→ Size Value
→ Size Unit of Measure
→ Size Type Text
Storage and Handling Type
→ Handling Environment
Atmospheric Pressure (LV and HV)
→ Handling Environment Humidity
(LV and HV)
→ Handling Environment
Temperature (LV and HV)
→ Storage Environment Atmospheric
Pressure (LV and HV)
→ Storage Environment Humidity (LV
and HV)
→ Storage Environment Temperature
(LV and HV)
→ Special Storage Conditions
→ Unit of measure
Sterilization Method
→ Device packaged as Sterile
→ Requires Sterilization prior to use.

UDI
MASTER DATA MANAGEMENT
Presenter : Alan

Master Data Distribution
All the required medical device data is dispersed across various
systems within the organization and may not be available in the
necessary format.
E.g. ERP, PLM, DMS, Excel sheets, Quick books, paper based
documents, etc…
Required medical device regulatory data should be identified
through a well integrated Master Data Management strategy.
The acquired data should be migrated, normalized, collated and
validated as per FDA guidelines and specifications.
Controlled vocabularies also should be identified and
normalized according to FDA specifications.

UDI Data Management
UDI DATA
CONVERSION
HL7 SPL
COMPLIANCE
Master Data Management
Identifying present data and application architecture
Location and Migration of master data present at multiple units and sites
Collection, Aggregation and Refinement of required data
Format Readiness Management
Preparing the product and regulatory data in the required format
Data Normalization and Validation based on FDA requirements
XML Conversion into validated SPL, as per HL7 and FDA 21 CFR Part 11 standards
Proof reading of GUDID data elements and Controlled Vocabularies
Establishment registration, listing and labeling
UDI data reports prepared and sent giving transparency of the submission status
Acquiring FDA GUDID Data Elements (DUNS, GMDN, Product Characteristics,
Labeler and Packaging Information, etc)

Recent Updates
Addition of a new PI; Donation Identification Number (DIN). This number is applicable only to HCT/P devices.
Two questions of MRI Safety are combined into one. What MRI safety information does the labeling contain? The
LOVs include – MR Safe, MR Unsafe, MR Conditional and Labeling does not contain MRI Safety Information.
New additions to the list of values for Sterilization Method were added.
Changes to list of values for Size Type and Unit of Measure were made.
Date format change for Web Interface entry ONLY from yyyy/mm/dd to yyyy-mm-dd.
Support Contact Phone/Email changed to Customer Contact Phone/Email.
Ability to submit FDA Preferred Term (PT) Codes for GUDID submissions until a GMDN PT code can be obtained
from the GMDN Agency.
Sept 10, 2014 FDA Unique Device Identification System has published a Small Entity Compliance Guidance for
Industry.
Aug 20, 2014 FDA has released a FAQ for Unique Device Identifier System: Vol. 1.
Aug 15, 2014 FDA’s Center for Devices and Radiological Health (CDRH) has issued a letter extending the
September, 2014 UDI compliance deadline by one year for Class III Contact Lens and Intraocular Lens Labelers.

FREYR LEVERAGE
UDI COMPLIANCE EXPERTISE
Presenter : Rajiv

Freyr Roadmap to UDI Compliance
→ Freyr can assist your
organization with FDA’s
UDI Compliance to ensure
conformance with current
regulatory requirements &
mandates, manage the
Supply Chain, reduce your
Product’s Lifecycle and
enable faster Time-to-
market.
Keeping the timelines in mind, Freyr’s roadmap to help medical device companies to UDI
Compliance comprises of a 3-Step Process. This process signifies Freyr’s dedication to assist and
support medical device companies to attain industry compliance.
Freyr Consulting and
Advisory Services
1. Freyr IDENTITY
2. UDI Enterprise Application Interfaces (Custom
Bolt-on Solutions)
3. Operational Data Management
• Comprehensive Gap
Analysis Document
• GUDID Account
Creation
• Sample Submission
Ready XML Files
• UDI Awareness
workshop
• Collation of GUDID
Attributes
• Generation of XML
documents
• Validation of Data in
XML Documents
• Submission of DI
Information to
GUDID
• Technology Solution
• DI Data
Management
• HL7/SPL
Compliance
• PI Data
Maintenance
• Continuous UDI
Support
• Training & Support
UDI READINESS
ASSESSMENT/
GAP ANALYSIS
DI IMPLEMENTATION
& SUBMISSION
MANAGEMENT
LIFE CYCLE
MANAGEMENT

Freyr’s Comprehensive UDI Services & Solutions
Freyr IDENTITY
UDI Strategy &
Business Consulting
Device Information
Lifecycle Management
Freyr UDI
Centre of Excellence
(CoE)
Regulatory Intelligence
for UDI
UDI Technology Services
UDI Managed
Services
• UDI Readiness assessment
• Process consulting
• Workshop and training
• UDI data management and
harmonization
UDI Strategy & Business Consulting
• Device information lifecycle
management
Device Information Management
• Building custom validated
Enterprise scale applications
• Barcode, RFID labelling
services
• Automatic identification of
devices in supply chain
UDI Technology Services
• Device information
management
• GUDID Submission
• Production Information
management
Freyr IDENTITY
• Maintaining consistent
track of all the new
guidelines and
mandates
Regulatory Intelligence
for UDI
• End-to-end Operational UDI
data services
• Submissions and validations
UDI Managed Services

Freyr IDENTITY (UDI Software Solution)
Freyr IDENTITY leverages the Plan, Process and Training methodology to offer an end-to-
end UDI compliance solution.
XML Conversion: Freyr IDENTITY converts the device attribute data in to XML based on
SPL and HL7 protocols
Data Validation: Freyr IDENTITY has an inbuilt Validator that uses GUDID business rules
and pre-validates the configured XML data.
Data Submission: The validated XML submission is uploaded to GUDID thru the
electronic submission gateway (ESG).
Version Management: Freyr IDENTITY deploys an efficient Version-control system to
ensure that the updates made to published device data are captured and organized in
indexed and searchable files.
Pre-built Training: Freyr offers a comprehensive pre-built training either in a hosted
environment or in the on-premises deployment, to empower skills and enable
compliance with UDI practice.
Lifecycle Management: Right from deployment to training and regular maintenance,
Freyr IDENTITY offers a complete solution to companies to easily manage multiple
lifecycles of the updated, modified device information and frequent submissions.

Freyr Fact Sheet
o
New Jersey
o
London
o
Hyderabad
→ Headquartered in New Jersey, USA with
Regulatory Operations & Data Centre in
Cranbury, NJ, USA
→ Global Regulatory Operations &
Development Centre in Hyderabad, India,
Asia’s leading Bio-Tech Hub
→ Robust Information Security and Quality
ISO 9001 & ISO 27001 Certified Processes
with state-of-the-art infrastructure and BCP
& DR site
→ Best-in-class Regulatory Consulting,
Technology and high-value/ low-cost
Outsourcing Services
→ Rapidly growing strong 350+ team of
regulatory, scientific, technology &
consulting professionals
o
Headquarters
Global Operations & Data Center
o
Global Operations & Development Center
Freyr, is a fast-growing, Global Regulatory Solutions & Services company
with an exclusive focus on the entire Regulatory value-chain.
Freyr specializes in offering high-value Consulting, Software & Operations
Outsourcing Services of Regulatory Affairs, Operations & Information
Management functions to Large & Small-Medium Life Sciences companies.
Freyr is the preferred partner to Top 10 Fortune 50 Bio-
Pharma & Consumer Healthcare and several Small-
Medium Pharma & Life Sciences Companies.

Freyr Regulatory Centers of Excellence (CoE)
CoEs / SERVICES Software / Cloud
Process / Business
Consulting
Outsourcing Services Resource Fulfillment
Regulatory Publishing    
Regulatory Affairs   
Regulatory CMC   
Labeling & Artwork    
Regulatory Information
Management
   
Consumer Healthcare
Regulatory
  
Regulatory Intelligence    
R&D Software & Support   
Health Authority Directives
EVMPD/ IDMP    
UDI    

Questions?

US Headquarters
1 Bell Street, Maidenhead,
Berkshire, SL6 1BU
Phone +44 1133 508632
103 Carnegie Centre, Suite
300, Princeton, NJ – 08540
1 Farr View Dr, STE 5E ,
Cranbury Township, NJ
08512
Phone +1 908 345 5984
UK
North America
Operations Center
Lanco Hills Technology
Park, Manikonda,
Hyderabad, India
Phone +91 40 4848 0999
India Global
Operations Center
contactus@freyrsolutions.com
Thank You!

FREYR UDI VISION SERIES SESSION 1 - UDI READINESS

Recommended

Recommended

More Related Content

What's hot

What's hot (20)

Viewers also liked

Viewers also liked (17)

Similar to FREYR UDI VISION SERIES SESSION 1 - UDI READINESS

Similar to FREYR UDI VISION SERIES SESSION 1 - UDI READINESS (20)

Recently uploaded

Recently uploaded (20)

FREYR UDI VISION SERIES SESSION 1 - UDI READINESS