free webinar on udi

presents

UniqueDeviceIdentification(UDI):What&HowwithinoverallMedicalWhat&HowwithinoverallMedical

DeviceValueChain

ByJimPetragnani

PlanningandImplementationoftheMedicalDeviceRegulation(UDI)

2015MakroCare.AllRightsReserved. www.makrocare.com

AboutMakroCare

AwardsYear

Established

Over15yearsofLifeSciencesCoreConsultingexperience

GlobalAccess ClientsEmployeesProprietary

Frameworks/Tools

1996(HQ:NJ USA)

p y

650+FTEs140+ C lt t

Frameworks/Tools

NAVAVistaar

(HQ:NJ,USA)Privatelyheld

14Global Offices 8 of Global Top 20

140+ Consultants RIMtrackjarTreeTULAClinMetanoiamNAAMGlobalOffices 8 ofGlobalTop20

150+Small/MidlevelmNAAMmEDCmIRT


ISO 9001 ISO 14155ISO 27001 ISO 20000

AboutMakroCare

MedicalDevicePractice

Regulatory Compliance

RegulatoryIntel&RegulatoryStrategyDevelopment

AdvisorySupportandRoadmapConsulting Biocompatibility Assurance cases Testing

Qualitymanagementsystemconsultingandimplementation

SOPsandQualityManualDevelopmenth d d d h Biocompatibility,Assurancecases,Testing

requirements

RegulatoryWritingandSubmissionsDevelopment(510k,PMA,,TechnicalFiles,DHF,etc.)

EstablishmentRegistrationandProductListing

ThirdPartyAuditsandOversight SystemsandUtilitiesValidation DesignControl RiskManagement

ClinicalDevelopment PostMarketSupport

ClinicalStrategy,StudyDesigningandmanagement

Monitoring(Central/Onsite) Clinical Data Management, Stat, Analysis,

PostmarketFollowUpStudies(RegulatoryandMarketing)

Scientific/Medicaladvisory MDR / Annual Reports / Supplements


ClinicalDataManagement,Stat,Analysis,Writing

eClinical technology

MDR/AnnualReports/Supplements

MakroCares Approach

Design>Implement>Train>Transferg p

UDIComplianceSolution

C lti d Ad i

Phase1:Design

Phase2:Implement

Phase3:Report

ConsultingandAdvisorySupportfromSerialization,SupplyChainandComplianceExperts

SourceDataIdentification

DataMappingSOPandProcedure

PlanDevelopment Implementation

Guidance

Implementation

DatabaseSetupMigration/Integration Initial work volume Initialworkvolumemanagement

DataQualityandComplianceteam


MakroCares Approach

Design>Implement>Train>Transferg p

UDIComplianceSolutionPhase3:Phase1: Phase2:

l ReportDesign Implement

HL7SPLUDIxmltoolWebBased/OnpremiseGenerateXMLFDASubmissions

ManageSubmissionLifecycle

EasytoUse IntegrateddashboardPayasperuseOngoing development forOngoingdevelopmentforglobalcompliancerequirements

Part11Compliant


presents

UniqueDeviceIdentification(UDI):What&HowwithinoverallMedicalWhat&HowwithinoverallMedical

DeviceValueChain

ByJimPetragnani

PlanningandImplementationoftheMedicalDeviceRegulation(UDI)


UDI:PlanningandImplementation

St 1 D l i th UDI li lStep1.DevelopingtheUDIcomplianceplan

1. Briefseniormanagementonprojectscopeandprovideresourcerequirementswithcost

2. Receiveseniormanagementprojectapproval

3. Buildtherightteammemberswhoarededicatedandhavetherightcomplementof

product/processknowledge

4. Defineclearroles,accountabilitiesandresponsibilities

5. UnderstandtherequirementsoftheMedicalDeviceRegulation

6. Engageinanapproachthatwillconfirmassumptionsearlyandallowforjointagreed

adjustmenttotheplan

7. Evaluatethesupplychainbusinessprocesses

8. Producegapassessmentandgenerategapfindingsandconclusions

9. Prepareforinnovativeandsustainablechangetothegoforwardenvironment monitor

publications

10. Planandprovidethatproductexpertsenableknowledgetransfer

11. DevelopaplanforChangeManagement



St 2 U d t di th M hi R d bl T h lStep2.UnderstandingtheMachineReadableTechnology

1. Thatnumberonthemedicaldevice,It'snotjustanumber....Itmeanssomething

2. Standardproductidentifier

3. Reachouttotheglobalcommunity

4. Benefittothemedicalcommunity

5. Bettertraceability

6. Expediterecalls



St 3 Ch M tStep3. ChangeManagement

1. Createcompellingstoryorbusinesscase

2. Buildateamwhoarefullycommittedtothechangeinitiative

3. Createthevision

4. Communication,Communication,Communication

5. Startwith"shortterm"wins



St 4 Ri k A t k i th t il f f t hStep4. RiskAssessmentkeepingthesystemagileforfuturechanges

1. Proactivelyidentifyandmanagerisks

2. AssessLabelingchanges GlobalPackaging

3. SupplyChaincontinuityplanning



St 5 I l t ti f UDI l th l h iStep5. ImplementationofUDIplanacrossthevaluechain

1. Reviewwithprojectteamkeypointsofrequirement

2. Identifytherepresentativeproductsforassessments

3. Buildimplementationroadmap,resourcingincludingcost

4. Identifylowimpactproductdeviceforimplementationaspilotproject

5. Presentimplementationrecommendationsandvalidatewithstakeholders

6. Parallelprocesslowimpactproductdevice

7. Evaluateandcommunicateresultsof"pilot"product



St 6 Id tif i th d t f FDA tiStep6. IdentifyingthedatasourcesforFDAreporting

1. DevelopUDIdatasourcemap

2. DevelopUDIdatabaseforFDAReporting

3. SubmitinformationtoFDAwhichwillbeusedtopopulatetheUniqueDevice

IdentificationDatabase(GUDID)



C li D t

1yearafterpublicationofthefinalrule(September24,2014)

ThelabelsandpackagesofclassIIImedicaldevicesanddeviceslicensedunderthePublicHealthServiceAct(PHSAct)mustbearaUDI. 801.20.Datesonthelabelsofthesedevicesmustbeformattedasrequiredby 801.18.Dataforthesedevices

ComplianceDates

mustbesubmittedtotheGUDIDdatabase. 830.300.A1yearextensionofthiscompliancedatemayberequestedunder 801.55;sucharequestmustbesubmittednolaterthanJune23,2014.ClassIIIstandalonesoftwaremustprovideitsUDIasrequiredby 801.50(b).

2yearsafterpublicationofthefinalrule(September24,2015)

Thelabelsandpackagesof implantable,lifesupporting,andlifesustainingdevices mustbearaUDI. 801.20.Datesonthelabelsofthesedevicesmustbeformattedasrequiredby 801.18.

AdevicethatisalifesupportingorlifesustainingdevicethatisrequiredtobelabeledwithaUDImustabear UDI as a permanent marking on the device itself if the device is intended to be used more than oncebearUDIasapermanentmarkingonthedeviceitselfifthedeviceisintendedtobeusedmorethanonceandintendedtobereprocessedbeforeeachuse. 801.45.StandalonesoftwarethatisalifesupportingorlifesustainingdevicemustprovideitsUDIasrequiredby 801.50(b).

D t f i l t bl lif ti d lif t i i d i th t i d t b l b l d ith UDIDataforimplantable,lifesupporting,andlifesustainingdevicesthatarerequiredtobelabeledwithaUDImustbesubmittedtotheGUDIDdatabase. 830.300.



C li D t (C t )


ClassIIIdevicesrequiredtobelabeledwithaUDImustbearaUDIasapermanentmarkingonthedeviceitselfifthedeviceisadeviceintendedtobeusedmorethanonceandintendedtobereprocessedbeforeeachuse.801.45.

ComplianceDates(Cont.)

ThelabelsandpackagesofclassIImedicaldevicesmustbearaUDI. 801.20.Datesonthelabelsofthesedevicesmustbeformattedasrequiredby 801.18.ClassIIstandalonesoftwaremustprovideitsUDIasrequiredby 801.50(b).

DataforclassIIdevicesthatarerequiredtobelabeledwithaUDImustbesubmittedtotheGUDIDqdatabase. 830.300.


AclassIIdevicethatisrequiredtobelabeledwithaUDImustbearaUDIasapermanentmarkingonthedeviceitselfifthedeviceisadeviceintendedtobeusedmorethanonceandintendedtobereprocessedbeforeeachuse. 801.45.

The labels and packages of class I medical devices and devices that have not been classified into class I class II orThelabelsandpackagesofclassImedicaldevicesanddevicesthathavenotbeenclassifiedintoclassI,classII,orclassIIImustbearaUDI. 801.20.Datesonthelabelsof all devices,includingdevicesthathavebeenexceptedfromUDIlabelingrequirements,mustbeformattedasrequiredby 801.18.

DataforclassIdevicesanddevicesthathavenotbeenclassifiedintoclassI,classII,orclassIIIthatarerequiredtob l b l d h b b d h d b belabeledwithaUDImustbesubmittedtotheGUDIDdatabase. 830.300.ClassIstandalonesoftwaremustprovideitsUDIasrequiredby 801.50(b).


ClassIdevices,anddevicesthathavenotbeenclassifiedintoclassI,classII,orclass IIIthatarerequiredtobelabeledwithaUDI,mustabearUDIasapermanentmarkingonthedeviceitselfifthedeviceisadeviceintendedto be used more than once and intended to be reprocessed before each use 801 45


2020) tobeusedmorethanonceandintendedtobereprocessedbeforeeachuse. 801.45.


UDI f t b FDA A dit d I i AUDIformatsbyFDAAccreditedIssuingAgency

This document contains information and links related to the format of the unique device identifier (UDI) for each FDAaccredited issuingagency. Each FDAaccredited issuing agency has a unique UDI format that has been approved by FDA during the initial accreditationprocess. Any changes to the format of the UDI by an issuing agency must be approved by FDA before implementation. Please contact theissuing agency directly to obtain a UDI and for any additional questions regarding the creation or implementation of the formatsissuing 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 informationare currently working on recommendations for UDI representation and transmission. When available, links to these documents will be availableat the UDI webpage: www.fda.gov/udi

GS1IssuingAgency

IssuingAgency

DataDelimiters

Identifier DatatypeHumanReadable

DatabaseField SizeAgency Delimiters

FieldSizeFieldSize

GS1 (01) DI Numeric 16 14

GS1 (11)Manufacturing/ProductionDate numeric[YYMMDD] 8 6

GS1 (17) ExpirationDate numeric[YYMMDD] 8 6

GS1 (10) Batch/LotNumber alphanumeric 22 20

GS1 (21) SerialNumber alphanumeric 22 20

GS1 MaximumBaseUDI alphanumeric 76 66


ex:(01)51022222233336(11)141231(17)150707(10)A213B1(21)1234


H lth I d t B i C i ti C il (HIBCC) I i AHealthIndustryBusinessCommunicationsCouncil(HIBCC)IssuingAgency

IssuingAgencyDataDelimiters

Identifier DatatypeHumanReadableFieldSize

DatabaseFieldsize

HIBCC + DI Alphanumeric 7to24 6to23HIBCC $ LotNumberOnly Alphanumeric 19 18HIBCC $$7 LotNumberOnly(alternativeoption) Alphanumeric 21 18

HIBCC $$ ExpirationDatefollowedbyLotNumber ExpDate:numeric[MMYY] 6 4

LotNumber:alphanumeric 18 18

HIBCC $$2 ExpirationDatefollowedbyLotNumber ExpDate:numeric[MMDDYY] 9 6


HIBCC $$3 ExpirationDatefollowedbyLotNumber ExpDate:numeric[YYMMDD] 9 6


HIBCC $$4 ExpirationDatefollowedbyLotNumber ExpDate:numeric[YYMMDDHH]

11 8


HIBCC $$5 ExpirationDatefollowedbyLotNumber ExpDate:numeric[YYJJJ]JulianDateformat

8 5

b l h i 8 8LotNumber:alphanumeric 18 18

HIBCC $$6 ExpirationDatefollowedbyLotNumber ExpDate:numeric[YYJJJHH]JulianDateformatwithHouroption

10 7


$ l b l l h


HIBCC $+ SerialNumberonly Alphanumeric 20 18


H lth I d t B i C i ti C il (HIBCC) I i A (C t )

IssuingAgency DataDelimiters Identifier DatatypeHumanReadableFieldSize

DatabaseFieldsize

HealthIndustryBusinessCommunicationsCouncil(HIBCC)IssuingAgency(Cont.)

HIBCC $$+7 SerialNumberonly(alternativeoption) Alphanumeric 22 18

HIBCC $$+ ExpirationDatefollowedbySerialNumber ExpDate:numeric[MMYY] 7 4

SerialNumber:alphanumeric 18 18

HIBCC $$+2 ExpirationDatefollowedbySerialNumber ExpDate:numeric[MMDDYY] 10 6


HIBCC $$+3 ExpirationDatefollowedbySerialNumber ExpDate:numeric[YYMMDD] 10 6


HIBCC $$+4 ExpirationDatefollowedbySerialNumber ExpDate:numeric[YYMMDDHH]

12 8


HIBCC $$+5 ExpirationDatefollowedbySerialNumber ExpDate:numeric[YYJJJ] 9 5


HIBCC $$+6 ExpirationDatefollowedbySerialNumber ExpDate:numeric[YYJJJHH] 11 7


HIBCC /S SupplementalSerialNumber,wherelotnumber Alphanumeric 20 18also requiredandincludedinmainsecondarydatastring

HIBCC /16D ManufacturingDate(supplementaltosecondarybarcode)

numeric[YYYYMMDD] 12 8

HIBCC MaximumBaseUDI Alphanumeric 70to87 58to75Ex of Human Readable Barcode: +H123PARTNO1234567890120/$$420020216LOT123456789012345/SXYZ4567890123 45678/16D20130202C


ExofHumanReadableBarcode:+H123PARTNO1234567890120/$$420020216LOT123456789012345/SXYZ456789012345678/16D20130202C


I t ti l C il f C lit i Bl d B ki A t ti (ICCBBA) I iInternationalCouncilforCommonalityinBloodBankingAutomation(ICCBBA)IssuingAgency

HumanReadable Database

IssuingAgency DataDelimiters Identifier DatatypeReadableBarcodeFieldSize

DatabaseFieldSize

ICCBBA =/ DI Alphanumeric 18 16

ICCBBA =, SerialNumber Alphanumeric 8 6

ICCBBA = DonationIdentificationNumber Alphanumeric 16 15

ICCBBA => ExpirationDate numeric[YYYJJJ] 8 6

ICCBBA =} ManufacturingDate numeric[YYYJJJ] 8 6

ICCBBA &,1 MPHOLotNumber Alphanumeric 21 18

ICCBBA MaximumBaseUDIforHCT/Ps Alphanumeric 79 67

ExofHumanReadableBarcode:=/A9999XYZ100T0944=,000025=A99971312345600=>014032=}013032&,1000000000000XYZ123



I t ti l C il f C lit i Bl d B ki A t ti (ICCBBA) I iInternationalCouncilforCommonalityinBloodBankingAutomation(ICCBBA)IssuingAgency(Cont.)

Eye Readable DatabasBloodBagsOnly

IdentifyingSymbol

Identifier DatatypeEyeReadableBarcodeFieldSize

DatabaseFieldSize

ICCBBA =) DIforbloodcontainers(bags) Alphanumeric 12 10

ICCBBA &)LotNumberforbloodcontainers(bags) Alphanumeric 12 10

ICCBBAMaximumBaseUDIforBloodBags Alphanumeric 24 20ICCBBA Bags Alphanumeric 24 20

ExofHumanReadableBarcode:=)1TE123456A&)RZ12345678



UDI I i A iUDIIssuingAgencies

1.FirmName: GS1Address: Princeton Pike Corporate Center, 1009 Lenox Drive, Suite 202, Lawrenceville, NJ 08648Address: PrincetonPikeCorporateCenter,1009LenoxDrive,Suite202,Lawrenceville,NJ08648ContactPerson: SiobhanOBara,SeniorVicePresident IndustryEngagementPhone: (609)6208046Email: [email protected]: http://www.gs1.orgDateofInitialAccreditation: December17,2013Initial Accreditation Granted through: December 17 2016InitialAccreditationGrantedthrough: December17,2016

ApplicationApprovalLetterInformationonUsingtheGS1SystemforUDIRequirements

2.FirmName: HealthIndustryBusinessCommunicationsCouncil(HIBCC)Address: 2525E.ArizonaBiltmoreCircle,Suite127,Phoenix,AZ85016ContactPerson: RobertA.Hankin,PhD.,PresidentandCEOPhone: (602)3811091Email: [email protected] b Sit htt // hib

3.FirmName: ICCBBAAddress: POBox11309,SanBernardino,CA924231309ContactPerson: PatDistler,TechnicalDirectorPhone: (909)7936516Email: [email protected] b Sit htt // i bbWebSite: http://www.hibcc.org

DateofInitialAccreditation: December26,2013InitialAccreditationGrantedthrough: December26,2016

ApplicationApprovalLetter

WebSite: http://www.iccbba.orgDateofInitialAccreditation: February12,2014InitialAccreditationGrantedthrough: February12,2017

ApplicationApprovalLetter



P j t Ti liProjectTimeline

Week1

Week2

Week3

Week4

Week5

Week6

Week7

Week8

Week9

Week101 2 3 4 5 6 7 8 9 10

EnterpriseProgramManagementOffice

N R l i C liNewRegulationCompliance

TASKORACTIVITY TIMELINED l i h UDI li Pl W k 1 W k 2DevelopingtheUDIcompliancePlan Week1 Week2

IdentifyingthedatasourcesforFDAReporting Week3 Week4

UnderstandingtheMachineReadableTechnology Week5

Change Management Plan Week 6ChangeManagementPlan Week6

RiskAssessmentRegister Week7

ImplementationofUDI Week7 10


Contact:Contact:

JimPetragnani andAaryak JoshiJ g y J

[email protected]

+19734810100extn 3043

www.makrocare.com

OneWashingtonPark,Suite1303,Newark, 07102,NJ(USA)


(USA)

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i th udi li lstep1