1 Unique Device Identifier (UDI) - Overview 6/21/2014 Behnaz MinaeiOffice of Surveillance and Biometrics Center for Devices and Radiological Health
2 Presentation Outline UDI Overview and Key Benefits GUDID Overview GUDID Key ConceptsGUDID AccountDI RecordHow to Get StartedHow to Contact Us
3 Unique Device Identification System 2007 FDAAA – the system, 2012 FDASIA – the timelines , 2012 Proposal - 77 FR 407362013 Final Rule- 78 FR 58786CDRH Learn Unique Device Identification (UDI) System - The Final Regulation Unique Device Identification (UDI) SystemUnique Device Identification (UDI) System - The Final RegulationGUDID Overview (with UDI Introduction)GUDID - Account Set-upCDRH Device Advice-UDIThe legislation, the 2007 FDA Amendments Act (FDAAA) established the statutory authority for the UDI system for medical devices. Then in 2012, The FDA Safety and Innovation Act (FDASIA) set the timelines for establishing the Unique Device Identification System, known as U D I. (Which you shouldn’t confuse with my uncle Udie – although he’s pretty unique too).The goal of the UDI system for medical devices is to accurately identify medical devices throughout their distribution and use and in use – to enhance patient safety.The 2013 final rule laid out FDA’s consideration of 270 sets of comments and the text of the regulations necessary to establish the UDI system. The final rule also gives the timetable of compliance dates which phase in these requirements and the conforming amendments, which are the changes to existing FDA regulations needed for UDI.In order to be familiar with these topics, you should view the UDI video on CDRH Learn and visit UDI page on CDRH Device Advice. We plan to cover these topics in depth, in future webinars.
4 Key Benefits of the UDI System Accurately identify a device through distribution and useImprove timeliness and effectiveness of device recallsIncorporation into adverse event reporting and device registries to facilitate improved signal detectionIntegration into Electronic Health RecordsAn easily accessible source of device information for patients and clinicians
6 Establishing the UDI System Step 1 Develop a standardized system to create unique device identifiers (UDI).Key PlayersFDA accredits the Issuing Agencies--GS1, HIBCC, ICCBBA accreditedIssuing Agencies operate systems to issue UDIs according to ISO 15459Labelers select Issuing Agencies to work with
7 Establishing the UDI System Step 2 Place the UDI in human readable (Plain Text) and machine readable (AIDC) formats on label and packaging, and for certain devices, on the device itself.Key PlayersLabelers – Label with intent to commercially distribute
8 Establishing the UDI System Step 3 Create, maintain, and use the UDI Database (GUDID).Key PlayersFDA creates and maintains GUDIDLabelers enter data into GUDIDPublic access data in the GUDID
9 UDI = Unique Device Identifier Device Identifier(DI) + Production Identifier(s)(PI)DI= mandatory, fixed portion of a UDI that identifies the specific version or model of a device and the labeler of that devicePI= a conditional, variable portion of a UDI that identifies one or more of the following when included on the label of the device:Lot or batch numberSerial numberExpiration dateManufacturing dateFor an HCT/P regulated as a device, the distinct identification code
10 Repository of key device identification information Contains ONLY the DI; PIs are not submitted to or stored in the GUDIDContains only PI flags to indicate which PI attribute(s) are on the device label
12 GUDID Web Interface Secure Web Application Submission of device information one record at a time by LabelersList of Data Elements and Definitions: GUDID Data Elements Reference Table - May 7, 2014 (XLS - 91KB)
20 GUDID HL7 SPL Submission Option HL7 = Health Level 7SPL = Structured Product LabelingSubmission of device information as xml files – one record at a timeUses the FDA Electronic Submissions Gateway (ESG) to transmit the fileTechnical specifications available on the UDI websiteTesting required prior to production submissionHL7 SPL Implementation Files (ZIP - 1.5MB)
22 GUDID Account Required for submission to GUDID Identifies Labeler organization - DUNS NumberEnables labelers to manage access to GUDID within their organizationGUDID account is created by FDA StaffGUDID account user information is not made public
24 DUNS Number DUNS = Data Universal Numbering System 9 digit number assigned by Dun & Bradstreet (D&B)Used to identify labeler organizations in GUDIDLabeler name and address is pulled from DUNS databaseLabeler name from D&B should match company name on device labelPrefer that labeler address from D&B match company address on device label
25 GUDID DUNS Numbers Organization DUNS identifies the labeler organization for a GUDID AccountLabeler DUNSidentifies the Labeler as shown on the medical device labelThird Party DUNSidentifies theindividual/companyauthorized to submit informationto GUDIDon behalf of labeler
27 GUDID User Roles Regulatory Contact Responsible for GUDID submission requirementsCoordinatorManages the GUDID account for assigned Labeler DUNS numbersLabeler Data Entry (LDE) UserResponsible for day to day entry, submission and management of device identification (DI) records
28 Third-Party Submitter Company/Individual authorized to submit to GUDID on behalf of the labelerWeb Interface Submitters – Labeler may designate third-party as Coordinator or LDE User.HL7 SPL Submitters –Labelers must identify third-parties on their GUDID Account RequestOnly those identified will be allowed to submit on behalf of labeler
29 GUDID Account – TO DOUnderstand GUDID Account structure and User RolesDUNS NumbersIdentify/obtain appropriate DUNS numbersVerify information in the D&B database is correct; update if neededGUDID User RolesIdentify individuals for the different GUDID User RolesEnsure they understand GUDID functionality and responsibility for their user roleNote: You need a GUDID Account regardless of the submission option you choose.
30 DI RecordDI Record = Device Identifier (DI) + GUDID attributes
31 DI Record – Key Concepts New DI Trigger Attributes –when changed, no longer represent the same device and require a new DI.“Device Packaged as Sterile?”DI Record Publish Date - determines when a DI record gets “published” and is available via public search.
32 DI Record – Key Concepts Grace Period - 7 calendar days, starts the day after the DI record is publishedWithin Grace PeriodAll DI record attributes are editable, except Publish DateEdits must take place via the same submission option used to initially submit the recordAfter Grace PeriodNew DI trigger attributes - not editableLimited editing of certain attributesPublish DateGrace Period Start DateGrace Period End DateFriday, May 9, 2014Saturday, May 10, 2014Friday, May 16, 2014
33 DI Record Life CycleDI Record Life Cycle = DI record states + business rulesDI record state determines applicable business ruleDraft DI RecordBusiness rules = N/APublish Date = N/AEditing = unlimitedPublic Search = NONot available via HL7 SPL Submission OptionUnpublished DI RecordBusiness rules = passPublish Date > todayPublished DI RecordPublish Date<=todayEditing = limitedPublic Search = YES
34 Moving between DI Record States Draft DI RecordPublished DI RecordUnpublished DI Record
38 DI Record – TO DO Gather your data GUDID Data Elements Reference Table,Global Medical Device Nomenclature (GMDN) Preferred Terms - *RequiredIdentify/obtain active GMDN preferred terms for your devices,FDA Listing Number - *RequiredIdentify/obtain correct Listing Number for your devices“Bake-in” data quality processes
39 How to Contact UsHL7 SPL submitters with FDA ESG questions --All other inquiries via FDA UDI Help DeskGUDID Account Request – production and testRegulatory questionsTechnical questions
40 FDA UDI Help Desk Submit question via the web, www.fda.gov/udi Please complete all fields on the web form!
41 FDA UDI Help Desk Question becomes a “case” in help desk tool Response will be sent to the you provideAsk follow-up questions by responding to the , will append the “case”Please ensure you can receive s from help desk – check your spam folder
43 UDI Compliance DatesSeptember 24, Class III devices, incl. class III stand alone software- Devices licensed under the PHS ActSeptember 24, Implantable, life-supporting and life-sustaining (I/LS/LS) devices, incl. stand alone software- Direct Marking of I/LS/LS for certain intended usesSeptember 24, Class II devices- Direct Marking for class III devices and devices licensed under the PHS Act, for certain intended usesSeptember 24, Class I devices and devices not classified class I, II, III- Direct Marking of class II devices for certain intended usesSeptember 24, Direct Marking of class I devices and devices not classified into class I, II or III, for certain intended uses