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www.ReedTech.com

+1‐800‐772‐8368
Agenda
Reed Tech Company Profile
FDA Unique Device Identifier (UDI) Requirements
Medical Device Manufacturers’ GUDID Challenges
Reed Tech GUDID Submission Solution
Q&A

www.ReedTech.com

2
Questions

Please send questions 
during the session via 
webinar “Chat”

www.ReedTech.com

3
Reed Tech Company Profile

www.ReedTech.com

4
Reed Tech Profile
A recognized leader in providing solutions 
for content and lifecycle management
Over 50 years of experience; founded in 1961
Over 900 employees 
Part of the LexisNexis family; 
a business unit of Reed Elsevier
Contractor to USPTO to process all patent 
applications and grants
Service Provider to over 700 Life Sciences companies

Certified to ISO 9002 
in 1998
Upgraded to ISO 
9001:2008 in 2008

www.ReedTech.com

Philadelphia Headquarters
Horsham, PA, USA
Washington Operations
Alexandria, VA, USA

HL7 Organization 
Member since 2005

5
Reed Tech – Life Sciences Services
Structured Product Labeling (SPL)
Preparation, Submission, and Lifecycle Management

• Service provider for over 700 life sciences companies
6 of 10 largest pharma manufacturers in the world; 
large (200+ labels) to small (1 label)
Over 26,000 SPLs created since FDA drug mandate in 2005
Most experienced SPL service provider in the industry

• FDA Electronic Submissions Gateway (ESG) service
Highest volume submitter of SPLs (over 13,000) 
Over 375 companies

www.ReedTech.com

6

SPL
Reed Tech – Life Sciences Services (continued)
Structured Product Labeling (SPL)
Preparation, Submission, and Lifecycle Management

• Expertise in all CDER, CBER, and CVM Drug SPL types
Branded/Generic; Rx/OTC
SPL Original/PLR, R3/R4/R5, LCR/ER/SID/LL
Human Health, Biologics/Vaccines, Animal Health, etc.

• Services for CDRH Medical Device UDI SPL (and IFU SPL)
Analysis, Data Aggregation, and Data Validation
SPL Build, Submission, and Change Management
Participated in FDA SPL‐UDI pilot submission program (Oct 2012)

www.ReedTech.com

7

SPL
FDA UDI Requirements for 
Medical Devices

Please send questions
during the session
to “Staff” via webinar “Chat”

www.ReedTech.com

8
FDA’s Purpose and Public Health Benefits of UDI
Device UDI enhances and provides support for:

• Global Visibility
• Medical Device recalls
• Adverse Events Reporting
• Tracking and tracing (reduced counterfeiting)
• Supply chain security and efficiencies
• Reduced medical errors
• Post‐market surveillance
• An easily accessible source of device information for 
patients, clinicians, and the public

www.ReedTech.com

9
UDI Implementation Timeline

Key FDA Actions
2013-09-24 FDA released UDI Final Rule and
Draft GUDID Guidance for Industry (database definition)
2013-11-?? Awaiting GUDID SPL Implementation Specification (SPL XML message definition).
Delay is due to federal government shutdown.
2013-11-25 Comment period for Draft GUDID Guidance for Industry will end. Final GFI TBD.
Reference: FDA UDI website

www.ReedTech.com

10
UDI Regulation Overview
Labeling
UDI (Device Id + Production Id) on Device Label & Pkg
UDI in plain-text (human readable) and
Automatic Id and Data Capture (AIDC) technology
• 1D/2D barcode, RFID, near-field communication…
• If AIDC is not visible, add disclosure
Date Format YYYY-MM-DD (2013-10-29)
UDI on “Device” Software

Direct Part Marking (DPM)
Permanently mark UDI on device itself
Multiple use and reprocessed devices

FDA Global UDI Database (GUDID) (“Good-I-D”)
Submit DI and device metadata
Public access, global model
www.ReedTech.com

GUDID

11
Final Rule Highlights
Device Packages:  UDI required on Unit of Use, Base Product, Level 1 Pkg, Level 
2 Pkg up to Shipping Container

Single Use Device Exception (multiple in 1 Pkg, any class/except 
implants): UDI required on device package, not required on device label
Convenience Kits: UDI required on kit, UDI not required on components
Combination Product: UDI required on product, UDI not required on 
components (special NDC cases)
Inventory Exception: +3 years after Class compliance date
Class III Extension: +1 year, if request is approved 
Manufacturer determines UDI update: based on new version/model 
number
Medical Device Reporting, Facility Annual Report: must include UDI
More items in Appendix
www.ReedTech.com

12
Medical Device Manufacturers’ 
GUDID Submission Challenges

Please send questions
during the session
to “Staff” via webinar “Chat”

www.ReedTech.com

13
UDI Implementation Challenges
Product
Design
Label,
DPM
Financial
Funding,
Budget

Manufacturing
Revised Label,
DPM
UDI
Governance
Analysis,
Planning,
Roadmap
Production
Control
MDM,
Inventory,
Supply Chain

Marketing
Publish,
Order Mgmt

All data may not
be in accessible
electronic format

Regulatory
Collect and
Submit Data to
FDA

www.ReedTech.com

Data is most
likely in disparate
systems

14
Results of Attendees Survey
Q1 - Estimate the total number of product
SKUs you need to submit to the FDA for all
classes. (309 responses)
Uncertain or Not Applicable
> 100,000
50,001 – 100,000
10,001 – 50,000
1,001 – 10,000
101 – 1,000
< 100

Q3 - How far along are you in identifying,
collecting and organizing the UDI data that
you will need to submit to the FDA? (309
responses)

28%
2%

Uncertain or Not Applicable

2%

Identification, etc. completed

3%

3%

Identification, etc. underway

12%

9%

Planning started

11%

20%

40%

26%

Not started

41%

0%

26%

60%

37%

0%

20%

40%

Q2 - What device classes does your
organization manufacture (select all that
apply)? (474 responses)

Q4 - What method would you prefer to use
to submit your UDI data to the FDA? (307
responses)

Uncertain or Not Applicable
Class I
Class II
Class III

Uncertain or Not Applicable
Use the FDA GUDID web tool
Use a service provider
Use purchased software
Use internally developed tool

21%
40%
64%
29%

0%

www.ReedTech.com

20%

40%

60%

80%

65%
14%
4%
4%
12%

0%

15

20%

40%

60%

80%
GUDID Data Collection and Submission Steps

www.ReedTech.com

16
GUDID Data Submission Plans
1. Evaluate your “data situation” (location, gaps, owners, formats, etc.)
2. Determine your best GUDID data submission method/tool
3. Collect, Normalize, and Validate source GUDID data
• If necessary, capture data from Label (e.g., single use icon)
• If desired, collect additional data fields for future UDI submissions to 
•
•

international Regulatory Authorities and/or your internal purposes
Merge partial records from multiple “data sources”
“Normalize” data to FDA GUDID specs 
(e.g., Business Rules, Controlled Vocabularies)

4. For Manual Entry: enter data via FDA GUDID Tool
5. For Automated Entry:
• Create fully‐valid SPL UDI submissions per FDA business rules
• Submit SPL UDIs to FDA via ESG (AS2)
6. Submit changes/revisions
www.ReedTech.com

17
GUDID Data Record

GUDID Data Record
Approximately 55 Fields
Product ID Elements 
(Pri DI, Sec DI, UoU DI, DPM DI, 
GMDN)
Regulatory Elements
(FDA Listing #, Auth. #, ProCode)
Labeler and Contacts
Characteristics 
(Sterile, Size, Production Control)
Package Elements (Pkg DI, Qty)
…
Reference: Appendix B, Draft GUDID Guidance for Industry

www.ReedTech.com

18
GUDID Data Submission Options
Submission
Method

Description/Comments

FDA GUDID
Tool

• You (or third party) enter data
directly into the FDA GUDID
• Transcription error concern
• Low volume

Outsourced
Service

• External provider accepts your data,
builds and submits SPLs to FDA via
the ESG on your behalf

Technology Cost

• “No” tool cost

SaaS
• Use external tool to collect data,
(Software as
build and submit SPLs to FDA via
a Service)
the ESG

UDI
Software
Utility

Operations Cost
• Admin, data entry
& QA labor (yours
or third party)

• “No” tool cost

• “No” Admin &
operations labor
• Service cost

• “Rent” tool

• Admin &
operations labor

• Buy / build / upgrade an internal tool • “Own” tool
(buy/build/upgrade,
(ERP, PLM, MDM, Labeling or other)
• Admin &
install, validate,
to collect data and build SPLs
operations labor
train, maintain)
• Submit SPLs to FDA via the ESG
• ESG account (AS2)
(AS2)

www.ReedTech.com

19
Reed Tech GUDID SPL Submission Solution 
(SaaS or Outsourced)

Please send questions
during the session
to “Staff” via webinar “Chat”

www.ReedTech.com

20
Reed Tech GUDID SPL Solution (SaaS or Outsourced)

www.ReedTech.com

21
Reed Tech UDI Solution Benefits
Simple – minimal change to your current processes
Least intrusive – supply data from your existing systems, initially and 
for subsequent, on‐going maintenance
Cost effective – save IT costs (hardware and software purchase, 
installation, validation, and maintenance) 
Leverage Reed Tech's significant SPL preparation and ESG submissions 
experience

•
•
•

Over 26,000 SPLs created for over 700 customers
Over 13,000 ESG submissions for over 375 companies
Participated in FDA SPL‐UDI pilot submission program (Oct 2012); 
only company whose SPLs passed validation

Gain an experienced corporate partner – over 50 years of knowledge 
and expertise in data collection, content conversion, lifecycle 
management, and excellent customer service

www.ReedTech.com

22
Q&A

Please send questions
to “Staff” via webinar “Chat”

www.ReedTech.com

23
Reed Tech Contact Information

Gary Saner
Mark Bayer

Sr. Manager, Information Solutions – Life Sciences
VP, Business Development

Haley Lentz

Account Executive, Life Sciences

Web: 

www.ReedTech.com 

Email:

hlentz@reedtech.com

Phone:

+1‐800‐772‐8368

www.ReedTech.com

24
Appendix – Additional Final Rule Highlights
Label

• UDI (DI+PI) required on label and package in plain text and AIDC format 
• If AIDC is not visible, use disclosure (not the proposed AIDC symbol) 
• If Mfr/Expiration dates are displayed, use YYYY‐MM‐DD format and include dates in PI
Direct Part Marking: permanent UDI required, if multi‐use & reprocessed (not implants)
GMDN GUDID terms: freely available from FDA
All NHRICs and NDCs assigned to devices: rescinded by 2018‐09‐24, able to request use of 
legacy labeler code

Broad Exceptions: research (non clinical), investigational, vet device, exports, national stockpile
Stand‐alone Software: UDI required, downloads exempt from AIDC
Class I GMP Exception: UDI not required
Class I Exception: No PI required
Class I Retail Exception: UPC can be UDI
…

www.ReedTech.com

25

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