Free Webinar on Unique Device Identification.

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About MakroCare
Over 15 years of Life Sciences Core Consulting
experience
Year Established
Proprietary Frameworks/Tools
Global Access
Awards
Clients
Employees
650 FTEs 140 Consultants
NAVA Vistaar RIMtrack jarTree TULA ClinMetanoia mN
AAM mEDC mIRT
1996 (HQNJ,USA) Privately held
14 Global Offices
8 of Global Top 20 150 Small/Mid-level
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About MakroCare
Medical Device Practice
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MakroCares Approach
Design gt Implement gt Train gt Transfer
UDI Compliance Solution
Phase 2 Implement
Phase 3 Report
Phase 1 Design

• Consulting and Advisory Support from
  Serialization, Supply Chain and Compliance
  Experts
• Plan Development
• Implementation Guidance

• Source Data Identification
• Data Mapping
• SOP and Procedure Implementation
• Database Set-up
• Migration / Integration
• Initial work volume management
• Data Quality and Compliance team

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MakroCares Approach
Design gt Implement gt Train gt Transfer
UDI Compliance Solution
Phase 3 Report
Phase 1 Design
Phase 2 Implement

• HL7 SPL UDI xml tool
• Web Based / On-premise
• Generate XML FDA Submissions
• Manage Submission Lifecycle
• Easy-to-Use
• Integrated dashboard
• Pay-as-per use
• Ongoing development for global compliance
  requirements
• Part 11 Compliant

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Step 1. Developing the UDI compliance plan

1. Brief senior management on project scope and
   provide resource requirements with cost
2. Receive senior management project approval
3. Build the right team members who are dedicated
   and have the right complement of product/process
   knowledge
4. Define clear roles, accountabilities and
   responsibilities
5. Understand the requirements of the Medical Device
   Regulation
6. Engage in an approach that will confirm
   assumptions early and allow for joint agreed
   adjustment to the plan
7. Evaluate the supply chain business processes
8. Produce gap assessment and generate gap findings
   and conclusions
9. Prepare for innovative and sustainable change to
   the go-forward environment - monitor publications
10. Plan and provide that product experts enable
    knowledge transfer
11. Develop a plan for Change Management

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Step 2. Understanding the Machine Readable
Technology

1. That number on the medical device, It's not just
   a number....It means something
2. Standard product identifier
3. Reach out to the global community
4. Benefit to the medical community
5. Better traceability
6. Expedite recalls

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Step 3. Change Management

1. Create compelling story or business case
2. Build a team who are fully committed to the
   change initiative
3. Create the vision
4. Communication, Communication, Communication
5. Start with "short term" wins

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Step 4. Risk Assessment keeping the system agile
for future changes

1. Proactively identify and manage risks
2. Assess Labeling changes - Global Packaging
3. Supply Chain continuity planning

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Step 5. Implementation of UDI plan across the
value chain

1. Review with project team key points of
   requirement
2. Identify the representative products for
   assessments
3. Build implementation road map, resourcing
   including cost
4. Identify low impact product device for
   implementation as pilot project
5. Present implementation recommendations and
   validate with stakeholders
6. Parallel process low impact product device
7. Evaluate and communicate results of "pilot"
   product

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Step 6. Identifying the data sources for FDA
reporting

1. Develop UDI data source map
2. Develop UDI database for FDA Reporting
3. Submit information to FDA which will be used to
   populate the Unique Device Identification
   Database (GUDID)

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Compliance Dates
1 year after publication of the final rule (September 24, 2014) The labels and packages of class III medical devices and devices licensed under the Public Health Service Act (PHS Act) must bear a UDI. 801.20. Dates on the labels of these devices must be formatted as required by  801.18. Data for these devices must be submitted to the GUDID database. 830.300.A 1-year extension of this compliance date may be requested under 801.55 such a request must be submitted no later than June 23, 2014.Class III stand-alone software must provide its UDI as required by 801.50(b).
2 years after publication of the final rule (September 24, 2015) The labels and packages of implantable, life-supporting, and life-sustaining devices must bear a UDI.   801.20.Dates on the labels of these devices must be formatted as required by  801.18.  
2 years after publication of the final rule (September 24, 2015) A device that is a life-supporting or life-sustaining device that is required to be labeled with a UDI must a bear UDI as a permanent marking on the device itself if the device is intended to be used more than once and intended to be reprocessed before each use.   801.45.Stand-alone software that is a life-supporting or life-sustaining device must provide its UDI as required by  801.50(b).
2 years after publication of the final rule (September 24, 2015) Data for implantable, life-supporting, and life-sustaining devices that are required to be labeled with a UDI must be submitted to the GUDID database. 830.300.
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Compliance Dates (Cont.)
3 years after publication of the final rule (September 24, 2016) Class III devices required to be labeled with a UDI must bear a UDI as a permanent marking on the device itself if the device is a device intended to be used more than once and intended to be reprocessed before each use. 801.45.
3 years after publication of the final rule (September 24, 2016) The labels and packages of class II medical devices must bear a UDI.   801.20.  Dates on the labels of these devices must be formatted as required by 801.18.Class II stand-alone software must provide its UDI as required by 801.50(b).
3 years after publication of the final rule (September 24, 2016) Data for class II devices that are required to be labeled with a UDI must be submitted to the GUDID database.   830.300.
5 years after publication of the final rule (September 24, 2018) A class II device that is required to be labeled with a UDI must bear a UDI as a permanent marking on the device itself if the device is a device intended to be used more than once and intended to be reprocessed before each use. 801.45.
5 years after publication of the final rule (September 24, 2018) The labels and packages of class I medical devices and devices that have not been classified into class I, class II, or class III must bear a UDI. 801.20. Dates on the labels of all devices, including devices that have been excepted from UDI labeling requirements, must be formatted as required by  801.18.
5 years after publication of the final rule (September 24, 2018) Data for class I devices and devices that have not been classified into class I, class II, or class III that are required to be labeled with a UDI must be submitted to the GUDID database.   830.300.Class I stand-alone software must provide its UDI as required by  801.50(b).
7 years after publication of the final rule (September 24, 2020) Class I devices, and devices that have not been classified into class I, class II, or class III that are required to be labeled with a UDI, must a bear UDI as a permanent marking on the device itself if the device is a device intended to be used more than once and intended to be reprocessed before each use.   801.45.
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UDI formats by FDA-Accredited Issuing Agency
This document contains information and links
related to the format of the unique device
identifier (UDI) for each FDA-accredited issuing
agency.  Each FDA-accredited issuing agency has a
unique UDI format that has been approved by FDA
during the initial accreditation process.  Any
changes to the format of the UDI by an issuing
agency must be approved by FDA before
implementation.  Please contact the issuing
agency directly to obtain a UDI and for any
additional questions regarding the creation or
implementation of the formats. Please note that
standards development organizations that are
helping to promote standard adoption of UDI in
electronic health information are currently
working on recommendations for UDI representation
and transmission. When available, links to these
documents will be available at the UDI webpage
www.fda.gov/udi
GS1 Issuing Agency
Issuing Agency Data Delimiters Identifier Data type Human Readable Field Size Database Field Size
GS1 (01) DI Numeric 16 14
GS1 (11) Manufacturing/Production Date numeric YYMMDD 8 6
GS1 (17) Expiration Date numeric YYMMDD 8 6
GS1 (10) Batch/Lot Number alphanumeric 22 20
GS1 (21) Serial Number alphanumeric 22 20
GS1   Maximum Base UDI alphanumeric 76 66
ex (01) 51022222233336(11)141231(17)150707(10)A213B1(21)1234 ex (01) 51022222233336(11)141231(17)150707(10)A213B1(21)1234 ex (01) 51022222233336(11)141231(17)150707(10)A213B1(21)1234 ex (01) 51022222233336(11)141231(17)150707(10)A213B1(21)1234 ex (01) 51022222233336(11)141231(17)150707(10)A213B1(21)1234 ex (01) 51022222233336(11)141231(17)150707(10)A213B1(21)1234
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Health Industry Business Communications Council
(HIBCC) Issuing Agency
Issuing Agency Data Delimiters Identifier Data type Human Readable Field Size Database Field size
HIBCC DI Alphanumeric 7 to 24 6 to 23
HIBCC Lot Number Only Alphanumeric 19 18
HIBCC 7 Lot Number Only (alternative option) Alphanumeric 21 18
HIBCC Expiration Date followed by Lot Number Exp Date numeric MMYY 6 4
HIBCC Expiration Date followed by Lot Number Lot Number alphanumeric 18 18
HIBCC 2 Expiration Date followed by Lot Number Exp Date numeric MMDDYY 9 6
HIBCC 2 Expiration Date followed by Lot Number Lot Number alphanumeric 18 18
HIBCC 3 Expiration Date followed by Lot Number Exp Date numeric YYMMDD 9 6
HIBCC 3 Expiration Date followed by Lot Number Lot Number alphanumeric 18 18
HIBCC 4 Expiration Date followed by Lot Number Exp Date numeric YYMMDDHH 11 8
HIBCC 4 Expiration Date followed by Lot Number Lot Number alphanumeric 18 18
HIBCC 5 Expiration Date followed by Lot Number Exp Date numeric YYJJJ Julian Date format 8 5
HIBCC 5 Expiration Date followed by Lot Number Lot Number alphanumeric 18 18
HIBCC 6 Expiration Date followed by Lot Number Exp Date numeric YYJJJHH Julian Date format with Hour option 10 7
HIBCC 6 Expiration Date followed by Lot Number Lot Number alphanumeric 18 18
HIBCC Serial Number only Alphanumeric 20 18
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Health Industry Business Communications Council
(HIBCC) Issuing Agency (Cont.)
Issuing Agency Data Delimiters Identifier Data type Human Readable Field Size Database Field size
HIBCC 7 Serial Number only (alternative option) Alphanumeric 22 18
HIBCC Expiration Date followed by Serial Number Exp Date numeric MMYY 7 4
HIBCC Expiration Date followed by Serial Number Serial Number alphanumeric 18 18
HIBCC 2 Expiration Date followed by Serial Number Exp Date numeric MMDDYY 10 6
HIBCC 2 Expiration Date followed by Serial Number Serial Number alphanumeric 18 18
HIBCC 3 Expiration Date followed by Serial Number Exp Date numeric YYMMDD 10 6
HIBCC 3 Expiration Date followed by Serial Number Serial Number alphanumeric 18 18
HIBCC 4 Expiration Date followed by Serial Number Exp Date numeric YYMMDDHH 12 8
HIBCC 4 Expiration Date followed by Serial Number Serial Number alphanumeric 18 18
HIBCC 5 Expiration Date followed by Serial Number Exp Date numeric YYJJJ 9 5
HIBCC 5 Expiration Date followed by Serial Number Serial Number alphanumeric 18 18
HIBCC 6 Expiration Date followed by Serial Number Exp Date numeric YYJJJHH 11 7
HIBCC 6 Expiration Date followed by Serial Number Serial Number alphanumeric 18 18
HIBCC /S Supplemental Serial Number, where lot number also required and included in main secondary data string Alphanumeric 20 18
HIBCC /16D Manufacturing Date (supplemental to secondary barcode) numeric YYYYMMDD 12 8
HIBCC   Maximum Base UDI Alphanumeric 70 to 87 58 to 75
Ex of Human Readable Barcode H123PARTNO1234567890120/420020216LOT123456789012345/SXYZ4567890123 45678/16D20130202C Ex of Human Readable Barcode H123PARTNO1234567890120/420020216LOT123456789012345/SXYZ4567890123 45678/16D20130202C Ex of Human Readable Barcode H123PARTNO1234567890120/420020216LOT123456789012345/SXYZ4567890123 45678/16D20130202C Ex of Human Readable Barcode H123PARTNO1234567890120/420020216LOT123456789012345/SXYZ4567890123 45678/16D20130202C Ex of Human Readable Barcode H123PARTNO1234567890120/420020216LOT123456789012345/SXYZ4567890123 45678/16D20130202C Ex of Human Readable Barcode H123PARTNO1234567890120/420020216LOT123456789012345/SXYZ4567890123 45678/16D20130202C
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International Council for Commonality in Blood
Banking Automation (ICCBBA) Issuing Agency
Issuing Agency Data Delimiters Identifier Data type Human Readable Barcode Field Size Database Field Size
ICCBBA / DI Alphanumeric 18 16
ICCBBA , Serial Number Alphanumeric 8 6
ICCBBA Donation Identification Number Alphanumeric 16 15
ICCBBA gt Expiration Date numeric YYYJJJ 8 6
ICCBBA Manufacturing Date numeric YYYJJJ 8 6
ICCBBA ,1 MPHO Lot Number Alphanumeric 21 18
ICCBBA   Maximum Base UDI for HCT/Ps Alphanumeric 79 67
Ex of Human Readable Barcode/A9999XYZ100T0944,000025A99971312345600gt014032013032,1000000000000XYZ123 Ex of Human Readable Barcode/A9999XYZ100T0944,000025A99971312345600gt014032013032,1000000000000XYZ123 Ex of Human Readable Barcode/A9999XYZ100T0944,000025A99971312345600gt014032013032,1000000000000XYZ123 Ex of Human Readable Barcode/A9999XYZ100T0944,000025A99971312345600gt014032013032,1000000000000XYZ123 Ex of Human Readable Barcode/A9999XYZ100T0944,000025A99971312345600gt014032013032,1000000000000XYZ123 Ex of Human Readable Barcode/A9999XYZ100T0944,000025A99971312345600gt014032013032,1000000000000XYZ123
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International Council for Commonality in Blood
Banking Automation (ICCBBA) Issuing Agency (Cont.)
Blood Bags Only Identifying Symbol Identifier Data type Eye Readable Barcode Field Size Database Field Size
ICCBBA ) DI for blood containers (bags) Alphanumeric 12 10
ICCBBA ) Lot Number for blood containers (bags) Alphanumeric 12 10
ICCBBA   Maximum Base UDI for Blood Bags Alphanumeric 24 20
Ex of Human Readable Barcode )1TE123456A)RZ12345678 Ex of Human Readable Barcode )1TE123456A)RZ12345678 Ex of Human Readable Barcode )1TE123456A)RZ12345678 Ex of Human Readable Barcode )1TE123456A)RZ12345678 Ex of Human Readable Barcode )1TE123456A)RZ12345678 Ex of Human Readable Barcode )1TE123456A)RZ12345678
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UDI Issuing Agencies
1. Firm Name GS1Address Princeton Pike
Corporate Center, 1009 Lenox Drive, Suite 202,
Lawrenceville, NJ 08648Contact Person Siobhan
OBara, Senior Vice President - Industry
EngagementPhone [phone]Email sobara_at_gs1
us.orgWeb Site http//www.gs1.orgDate of
Initial Accreditation December 17, 2013Initial
Accreditation Granted through December 17,
2016 Application Approval Letter Information on
Using the GS1 System for UDI Requirements
2. Firm Name Health Industry Business
Communications Council (HIBCC)Address 2525 E.
Arizona Biltmore Circle, Suite 127, Phoenix, AZ
85016Contact Person Robert A. Hankin, PhD.,
President and CEOPhone [phone]Email rha
nkin_at_hibcc.orgWeb Site http//www.hibcc.org Dat
e of Initial Accreditation December 26,
2013Initial Accreditation Granted
through December 26, 2016 Application Approval
Letter
3. Firm Name ICCBBAAddress PO Box 11309, San
Bernardino, CA 92423-1309Contact Person Pat
Distler, Technical DirectorPhone (909)
793-6516Email pat.distler_at_iccbba.orgWeb
Site http//www.iccbba.org Date of Initial
Accreditation February 12, 2014Initial
Accreditation Granted through February 12,
2017 Application Approval Letter
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Project Timeline
Week 1 Week 2 Week 3 Week 4 Week 5 Week 6 Week 7 Week 8 Week 9 Week 10

Enterprise Program Management Office Enterprise Program Management Office Enterprise Program Management Office Enterprise Program Management Office Enterprise Program Management Office Enterprise Program Management Office Enterprise Program Management Office Enterprise Program Management Office Enterprise Program Management Office Enterprise Program Management Office
New Regulation Compliance
TASK OR ACTIVITY TIMELINE
Developing the UDI compliance Plan Week 1 - Week 2
Identifying the data sources for FDA Reporting Week 3 - Week 4
Understanding the Machine Readable Technology Week 5
Change Management Plan Week 6
Risk Assessment Register Week 7
Implementation of UDI Week 7 - 10
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Contact
Jim Petragnani and Aaryak Joshi
medtech_at_makrocare.com
1-973-481-0100 extn 3043
www.makrocare.com