Published on March 5, 2014
www.ReedTech.com www.ReedTech.com 1 +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 Appendix 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 725 Life Sciences companies ISO Certified since 1998 (9001:2008) www.ReedTech.com HL7 Member since 2005 5 Philadelphia Headquarters Horsham, PA, USA Washington Operations Alexandria, VA, USA GS1 Solution Partner
Reed Tech – Life Sciences Services Structured Product Labeling (SPL) Preparation, Submission, and Lifecycle Management • Service provider for over 725 life sciences companies 6 of 10 largest pharma manufacturers in the world; large (200+ labels) to small (1 label) Over 28,000 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 14,000) Over 400 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
UDI Implementation Timeline Key FDA Documents 2013-09-24 2013-11-21 2014-02-13 TBD UDI Final Rule and Draft GUDID Guidance for Industry (database definition) Draft GUDID SPL Implementation Specification (SPL XML message definition) Revised Draft GUDID SPL Implementation Spec (folder name, FDA PT Code) Final GUDID GFI and Final GUDID SPL Implementation Spec Reference: FDA UDI website www.ReedTech.com 9
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 Marking (DM) Multiple use and reprocessed devices Permanently mark UDI on device FDA Global UDI Database (GUDID) Submit DI and device attributes Public access, global model GUDID Reporting – include UDI as available www.ReedTech.com 10
UDI on Label vs. GUDID Submission Data Definitions • UDI = DI + PI(s) • GUDID Data = DI (not PI) + Device Attributes = 55 Submitted Fields www.ReedTech.com 11
GUDID Data From Label Reference: Indira Konduri, FDA, “The GUDID Account,” webinar Jan 30 2014 www.ReedTech.com 12
GUDID Data Elements 55 Submitted by Labeler (some can have multiple values) 7 Populated by FDA GUDID System (indicated by *) www.ReedTech.com 13
GUDID Data Record GUDID Data Record 55 Submitted Data Elements 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) www.ReedTech.com 14
Medical Device Manufacturers’ GUDID Submission Challenges Please send questions during the session to “Staff” via webinar “Chat” www.ReedTech.com 15
Results of Attendees Survey How far along are you in identifying, collecting and organizing the UDI data that you will need to submit to the FDA? (407 responses) If you are submitting Class III UDI data to the FDA, and taking into consideration the September 24, 2014 deadline, when are you anticipating making your submissions? (369 responses) Have you decided what method you will use to submit your UDI data to the GUDID? (474 responses) If yes, which of the following methods do you prefer? (286 responses) www.ReedTech.com 16
GUDID Data Submission Methods * SaaS – Software as a Service www.ReedTech.com 17
GUDID Data Submission Methods Comparison Submission Method Description/Comments FDA GUDID Web Interface • You (or third party) enter data directly into the FDA GUDID • Best suited for low volume • Transcription error concern • “No” software cost • Admin, data entry, & QA labor (yours or third party) • Use external software to collect data, build, and submit SPLs to FDA via the ESG • High volume, electronic submissions • “Rent” software • Admin & operations labor • “No” Admin & operations labor • Service cost Hosted Software (Software as a Service) Technology Cost Operations Cost Outsourced Service • External provider accepts your data, builds, and submits SPLs to FDA via the ESG on your behalf • “No” software cost Internal Software • Buy / build / upgrade software (ERP, PLM, MDM, Labeling or other) to collect data and build SPLs • Submit SPLs to FDA via the ESG (AS2) • “Own” software (buy/build/upgrade, • Admin & install, validate, operations labor train, maintain) • ESG account (AS2) www.ReedTech.com 18
GUDID Submission Method Evaluation Selection Criteria • Determine Submission Data Location and Management Data Entry, Hosted, Outsourced, or Internal • Need 21 CFR Part 11 Compliance (for non‐FDA GUDID Tools) Device Labeler is responsible 3rd Party organization is not directly responsible • Consider Solution Capabilities and Expertise SPL Data Validation Controlled Vocabularies FDA ESG Submission ACK Processing and Reporting Maintenance 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 Complements your current internal processes Least intrusive Accepts data from your existing systems, initially and for subsequent, on‐going maintenance • Flexible data import options: manual entry, text file, XLS, XML • Data Transformations available per Reed Tech Synonym Vocabulary • Data Collection assistance available Cost effective • • Efficient, automated, bulk submissions Save IT costs (e.g., hardware/software purchase, installation, validation, maintenance) Flexible UDI solution • • Accommodates additional custom/proprietary data fields beyond FDA requirements Easy expansion for future UDI submissions to global regulatory authorities www.ReedTech.com 22
Reed Tech UDI Solution Benefits (continued) Compliant (21 CFR Part 11) preparation & submission to FDA • • Role‐based data management and approvals Preparation, submission, and acknowledgement reporting Leverage Reed Tech's significant SPL preparation and ESG submission experience • • • Over 28,000 SPLs created for over 725 customers Over 14,000 ESG submissions for over 400 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 23
Q&A Please send questions to “Staff” via webinar “Chat” www.ReedTech.com 24
Reed Tech Contact Information Gary Saner Mark Bayer Haley Lentz Sr. Manager, Information Solutions – Life Sciences VP, Business Development Account Executive, Life Sciences Web: www.ReedTech.com Email: firstname.lastname@example.org Phone: +1‐800‐772‐8368 www.ReedTech.com 25
Reed Tech UDI Resources Free upon request: Reed Tech GUDID Data Element List and Record Template Multiple Options To Weigh For Moving A UDI Into FDA’s Database “The Gray Sheet” January 6, 2014 UDI Training Course • • Interactive eLearning Course Collaborative with Lernia Training Solutions: www.Lernia‐ts.com Contact: Haley Lentz Account Executive, Life Sciences Email: email@example.com Phone: +1‐800‐772‐8368 Web: www.ReedTech.com www.ReedTech.com 26
FDA UDI Resources UDI “Home Page” • UDI Rule, GUID Guidance, Compliance Dates, Resources • http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIde ntification/default.htm UDI Help Desk • http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIde ntification/ucm368904.htm GUDID Information • Basics, Guidance, Account Request, GUDID Web Interface, HL7 SPL, GUDID Status • http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIde ntification/GlobalUDIDatabaseGUDID/default.htm GUDID Web Interface (Login) • https://gudid.fda.gov/gudid/ CDRH Learn (FDA Presentations) • • • • UDI System – The Final Regulation GUDID Overview (with UDI Introduction) GUDID ‐ Account Set‐up http://www.fda.gov/Training/CDRHLearn/ucm162015.htm#udi www.ReedTech.com 27
GUDID Data Collection and Submission Steps www.ReedTech.com 28
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 • Collect data from multiple sources; generate values as required • 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. Create FDA GUDID Account 5. Submit Data • For Manual, Individual Record Entry: enter data via FDA GUDID Web Interface • For Automated, Bulk Entry: Create fully‐valid SPL UDI submissions per FDA business rules Submit SPL UDIs to FDA via ESG (WebTrader, AS2) 6. Submit changes/revisions and new device records www.ReedTech.com 29
Final Rule Highlights Label • • • • • • • UDI (DI+PI) required on product label and package in plain text and AIDC (e.g., bar code) format Labeler creates UDI per FDA‐approved Issuing Agency specs (GS1, HIBCC, or ICCBBA) If Lot/Batch #, Serial #, Mfg date, Expir date, or HCT/P code appear on label, include each in PI If Mfg/Expiration dates are displayed on label, use YYYY‐MM‐DD format (AIDC date format can be different) If AIDC is not visible, use disclosure statement (not proposed AIDC symbol) If device is Stand‐alone Software, UDI required (on About or Help page), downloads exempt from AIDC Different UDI required on Unit of Use, Base Product/Pkg, Level 1 Pkg, Level 2 Pkg, up to Shipping Container Direct Marking: if multi‐use & reprocessed (not implants), permanent UDI is required • “reprocessed” infers a cleaning, wipe down, sterilization, or similar process between patients • “mark” can be a durable label affixed or attached to device or a physical part identification (engraving, etching, ball peen, etc.) GUDID: submit device DI+ Attributes to FDA GUDID by Class Compliance Dates Reporting: if UDI is available, include in Medical Device Reporting, Facility Annual Report, etc. www.ReedTech.com 30
Final Rule Highlights (continued) Broad Exceptions: research (non clinical), investigational, vet device, exports, national stockpile Inventory Exception: +3 years after Class compliance date Class III Extension: +1 year, if request (by June 23, 2014) is approved Class I GMP Exception: UDI not required Class I Exception: No PI required Class I Retail Exception: UPC can be UDI Single Use Device Exception: if multiple in 1 Pkg (any class, except implants), then UDI required on device package, not required on single use device label Convenience Kit Exception: UDI required on kit, UDI not required on components Combination Product Exception: UDI required on product, UDI not required on components (special NDC cases) GMDN Code: temporary FDA Preferred Term code (4 characters) is freely available from FDA GUDID Web Interface, actual GMDN Code (5 characters) is eventually needed All NHRICs and NDCs assigned to devices: rescinded by 2018‐09‐24, able to request use of legacy labeler code UDI Updates: Manufacturer determines updates based on new version/model number www.ReedTech.com 31
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