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www.ReedTech.com 1 www.ReedTech.com 1-800-772-8368 / +1-215-441-6438
www.ReedTech.com 1 www.ReedTech.com 1-800-772-8368 / +1-215-441-6438
www.ReedTech.com 2
Agenda
Reed Tech Company Profile
FDA UDI / GUDID Update (“Homework”)
Medical Device Manufacturers’ GUDID “To Do List”
Class III Now
Class II (and Class I) Soon
Reed Tech GUDID Submission Solution
Q&A
www.ReedTech.com 3
Questions
Please send questions during the session to “Staff” via webinar “Chat”
www.ReedTech.com 5
Reed Tech Profile
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 775 Life Sciences companies
A recognized leader in providing solutions for content and lifecycle management
ISO Certified since 1998 (9001:2008)
HL7 Member since 2005
Philadelphia Headquarters Horsham, PA, USA
Washington Operations Alexandria, VA, USA
GS1 Solution Partner
www.ReedTech.com 6
Reed Tech – Life Sciences Services
Structured Product Labeling (SPL) Preparation, Submission, and Lifecycle Management
• Service provider for over 775 life sciences companies 4 of the 5 largest pharma manufacturers in the world;
large (200+ labels) to small (1 label)
Over 30,000 SPLs created since FDA drug mandate in 2005
Most experienced SPL service provider in the industry
• Global customers Over 70 companies in over 25 countries outside the U.S.
• FDA Electronic Submissions Gateway (ESG) service Highest volume submitter of SPLs (over 14,000)
Over 425 companies
SPL
www.ReedTech.com 7
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)
Currently participating in CDRH GUDID Load Testing
SPL
www.ReedTech.com 8
FDA UDI / GUDID Update
“Homework”
Please send questions during the session
to “Staff” via webinar “Chat”
www.ReedTech.com 9
Direct Marking (DM)
Multiple use and reprocessed devices
Permanently mark UDI on device
Label
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…)
Date Format YYYY-MM-DD (2013-09-29)
FDA UDI Regulation Overview
FDA Global UDI Database (GUDID)
Submit DI and device attributes
Public access, global model GUDID
Reporting – include UDI as available
www.ReedTech.com 10
FDA UDI Compliance Timeline
Class IClass II
Compliance Timeline for UDI Implementation
Class IClass IIILL2
Class IIIGUDID data
submitted to FDA
and UDI on Label
UDI
Direct Marking3 Class III
1) FDA UDI Final Rule published 2013-09-24
2) ILL = Implantable, Life-supporting, and Life-sustaining devices
3) Direct Marking required on multiple-use and reprocessed devices
2014-09 2015-09 2016-09 2018-09Final Rule1
2020-09
ILL2
www.ReedTech.com 11
Key FDA UDI Documentation
2014-05-09 Data Elements & Issuing Agencies
SPL Implementation Specification
2013-09-24 Draft System & Database
2014-02-13 Revision (SPL Folder name, FDA PT, etc.)
2014-04-14 Revision (MRI, DIN, Vocab)
GUDID Guidance for Industry (GFI)
2013-11-21 XML Message Definition
UDI Final Rule
2013-09-24 CFR Legal Basis
Additional Support
Website, Webinars, Video, Help Desk, (FAQ)
2014-06-11 Final GFI (phase 1/2)
2014-06-27 Final GFI (complete 2/2)
www.ReedTech.com 12
UDI on Label vs. GUDID Submission Data
Definitions • UDI = DI + PI(s)
• GUDID Data = DI (not PI) + Device Attributes = 55 Submitted Fields
Medical Device
Manufacturer
Label
Data
Labeling
System
UDI on
Product & Pkg Label
GUDID
Submission Data
Source Data
· MDM
· ERP
· Regulatory
System
· Database/File
Systems
GUDID
DataGUDID
GUDID data
at FDA
www.ReedTech.com 13
Recent UDI Regulatory News
FDA Recent News
• May 2014: “No new Data Elements for 24 Sep 2014”
• “FDA GUDID Web Interface is designed for manufacturers with a small number of records. SPL is recommended for larger record volumes”
• “Class III Labelers can submit their Class II and I records now”
• CDRH performing interim manual quality checks on submissions
• Manufacturers that finished GUDID Pre-Production SPL Test Scenarios are now granted permission to create their GUDID Production Accounts
FDA Final Rule:
• Request time for Class III Extension expired June 23, 2014
• Request to Continue Labeler Code due by Sep 24, 2014
Health Canada
• 2 July 2014: Announced UDI plan to conform to IMDRF Guidelines. IMDRF dataset adds and deletes some data elements relative to the FDA data set
www.ReedTech.com 14
Medical Device Manufacturers’ GUDID “To Do List” Class III Now
Class II (and Class I) Soon
Please send questions during the session
to “Staff” via webinar “Chat”
www.ReedTech.com 15
Have you decided what method you will use to submit your UDI data to the GUDID? (316 responses)
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? (324 responses)
What device classes does your organization manufacture (select all that apply)? (324 responses)
www.ReedTech.com 16
Class II (and Class I) Benefits Early UDI Adoption
Customer Requests/Visibility
• Many hospitals and healthcare providers have started their UDI implementation process and are requesting their medical device suppliers to provide UDI information
• Manufacturers who adopt UDI early will have the benefit of early visibility in the GUDID to buyers of their products
Smooth Your Workload
• High volume of Class II (and Class I) products will require significant effort and time to collect, organize, and clean data – start early
Avoid Potential FDA Delays
• According to the FDA FURLS database, there are over 20 times more Class II products than Class III. Early adoption can mitigate the potential risks of FDA submission delays
International Compliance
• Early FDA UDI adopters will be in better position to meet future international deadlines
www.ReedTech.com 17
UDI / GUDID To Do List – Step 1
Analyze and Plan UDI Implementation • Review UDI Final Rule, Specs, Exceptions, Direct Marking, Timing, etc.
UDI Final Rule
Final GUDID Guidance for Industry
GUDID Data Elements Reference Table
SPL Implementation Files
• Evaluate your “data situation” (data location, gaps, owners, formats, etc.)
• Select Issuing Agency (GS1, HIBCC, or ICCBBA) for Product Identification (Primary DI, etc.) UDI Formats by FDA-Accredited Issuing Agency
• Select AIDC Technology (1D, 2D, etc.) for UDI Presentation on Label
www.ReedTech.com 18
UDI / GUDID To Do List – Step 2
Update Systems
• Production System, e.g., PLM, MDM, ERP
• Labeling System (templates, content)
www.ReedTech.com 19
UDI / GUDID To Do List – Step 3
Collect, Normalize, and Validate source GUDID data • Collect data from multiple sources; generate values as required
(Reed Tech GUDID Data Template available)
• 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)
• “Problematic” Data Elements
Labeler DUNS Number(s)
Device Identifiers
GMDN or FDA Preferred Term Values
Packaging Configuration
www.ReedTech.com 20
GUDID Data Elements (http://go.reedtech.com/62-elements)
55 Submitted by Labeler
(some can have multiple values)
7 Populated by FDA GUDID System
Identification Pri DI Issuing Agency
Primary DI #
Brand Name
Version/Model #
Catalog #
Device Description
Sec DI Issuing Agency
Secondary DI #
DM Exempt (Y/N)
DM DI Different (Y/N)
DM DI #
Labeler Labeler DUNS #
Labeler Name*
Labeler Address*
Contact Phone
Contact Email
Regulatory Publish Date
Distribution End Date
Distribution Status*
Premrkt Exempt (Y/N)
Premrkt Submission #
Supplement #
FDA Listing #
Product Code
Product Code Name*
GMDN Code
GMDN Name*
GMDN Definition*
Rx (Y/N)
OTC (Y/N)
Packaging Device Count
Unit of Use DI #
Kit (Y/N)
Pkg DI #
Pkg Quantity
Pkg Contains DI #
Pkg Type
Pkg Discontinue Date
Pkg Status*
Production Control Lot/Batch (Y/N)
Serial # (Y/N)
Mfg Date (Y/N)
Expiration Date (Y/N)
Donation Id # (Y/N)
Characteristics Single Use (Y/N)
Combo Product (Y/N)
HCT/P (Y/N)
Contains Rubber (Y/N)
Not Made with Rubber (Y/N)
MRI Safety Info
Size Type
Size Value
Size Unit
Size Text
Storage & Handling Type
S&H Low value
S&H High Value
S&H Unit
Storage Conditions
Sterile Pkg (Y/N)
Sterile Req'd
Sterile Method
* Populated by FDA GUDID System
www.ReedTech.com 21
GUDID Data Record (available upon request from Haley)
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 22
UDI / GUDID To Do List – Step 4
Choose Submission Method
* SaaS – Software as a Service
www.ReedTech.com 23
GUDID Data Submission Methods Comparison
Submission
Method Description/Comments Technology Cost Operations Cost
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 • Your admin, data
entry, & QA labor
Hosted
Software (Software as
a Service)
• Use external software to collect
data, build, and submit SPLs to
FDA via the ESG
• High volume submissions
• “Rent” software • Your admin &
operations labor
Outsourced
Service
• External provider accepts your data,
builds, and submits SPLs to FDA via
the ESG on your behalf
• “Rent” software
• “No” internal
Admin &
operations labor
• Service 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,
install, validate,
train, maintain)
• ESG account (AS2)
• Your admin &
operations labor
www.ReedTech.com 24
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
For Class III manufacturers, probably too late to implement internal software solution
www.ReedTech.com 25
UDI / GUDID To Do List – Step 5a
GUDID Pre-Production Account Set Up Process
• Request a Pre-Production (Test) GUDID Account Request Form from the FDA http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/GlobalUDIDatabaseGUDID/default.htm#account
www.ReedTech.com 26
UDI / GUDID To Do List – Step 5b
GUDID Pre-Production Account Set Up Process
• Complete the GUDID Account Request Form (Identify Labeler DUNS Numbers / Users) Attachment to email from the FDA (top half of page 1; 3 pages total)
www.ReedTech.com 27
UDI / GUDID To Do List – Step 5c
ESG Account Set Up Process (if using SPL Submissions)
• Request ESG Test Account
• Send Letter of Non-Repudiation
• Obtain and Send a Digital Certificate
• Register/Launch ESG Test Account
• Send Test Submissions (connectivity test, compliance test)
• Apply for ESG Production Account
• Launch ESG Production Account http://www.fda.gov/esg
Note: Reed Tech provides ESG account setup and ESG submission as part of our service
www.ReedTech.com 28
UDI / GUDID To Do List – Step 5d
ESG Account Testing Process (if using SPL Submissions)
• Complete 4 Test Scenarios – SPL submission into GUDID http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/GlobalUDIDatabaseGUDID/UCM376009.zip
Note: Reed Tech provides SPL Test submissions as part of our service
www.ReedTech.com 29
UDI / GUDID To Do List – Step 6
GUDID Production Account Set Up Process
• Request a Production GUDID Account
• Use same Application form as the GUDID Pre-Production Account Request
Go Live
• Submit existing device records
• 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)
On-going Maintenance
• Submit changes/revisions
• Submit new device records
www.ReedTech.com 30
Reed Tech GUDID SPL Submission Solution (SaaS or Outsourced)
Please send questions during the session
to “Staff” via webinar “Chat”
www.ReedTech.com 31
Reed Tech GUDID SPL Solution (SaaS or Outsourced)
Medical Device Manufacturer
Mfr (SaaS) or Reed Tech (Outsourced)
processes initial and maintenance FDA UDI submissions
Reed Tech Life Sciences Portal - UDI System
“The Last Mile”
ESG
FDA(or EU, PMDA, …)
FDA(or EU, PMDA, …)
GUDID
UDI Database
UDI Data ~~~~~
~~~~~
Custom Fields
SPL-UDIFiles
Controlled Vocab
Process ACK
Submit SPL
Edit/Maintain Build,
Validate, Approve
SPL
Prepare Data
Transform, Merge, Load, Validate & Review Data
ESG
PLM, MDM, ERP/MES,
RA, Labeling, ...
Reports
Data Collection
Import Bulk Files(XLS, XML,
GDSN, TXT)
Reports,
Updates
Terminology
Industry
Standards
Industry
Standards
www.ReedTech.com 32
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
• Multiple data import options: XLS, XML, GDSN, TXT
Save Time
• Data Transformations available per Reed Tech Synonym Vocabulary
• Data Aggregation
Cost effective
• Efficient, automated, bulk submissions
• Save IT costs (e.g., hardware/software purchase, installation, validation, maintenance)
www.ReedTech.com 33
Reed Tech UDI Solution Benefits (continued)
Flexible UDI Solution
• SaaS and Outsourced both available
• Accommodates additional custom/proprietary data fields beyond FDA requirements
• Easy expansion for future UDI submissions to other global regulatory authorities (Health Canada, EC, PMDA …)
• FDA GUDID Web Interface will have limited value in meeting non-U.S. GUDID mandates.
Compliant System
• Secure
• Validated
• 21 CFR Part 11 Compliant
Role-based data management and approvals
Reporting (audit trail, version history)
Only 55 days until FDA Class III submissions are due! Reed Tech Solution can easily meet this deadline
www.ReedTech.com 34
Reed Tech UDI Resources
Available from ReedTech.com: Reed Tech GUDID Data Element List
http://go.reedtech.com/62-elements
Reed Tech GUDID Record Template
Available upon request
Multiple Options To Weigh For Moving A UDI Into FDA’s Database “The Gray Sheet” 6 January 2014
http://go.reedtech.com/gray-sheet-article-0
UDI Training Course (in collaboration with Lernia Training Solutions)
https://secure.trainingcampus.net/uas/modules/trees/windex.aspx?rx=lernia-udi.trainingcampus.net
Sample GUDID Account Request Form
Available upon request
www.ReedTech.com 35
Reed Tech Contact Information
Haley Lentz Account Executive, Life Sciences
Email: [email protected]
Phone: 1-800-772-8368 or +1-215-441-6438
Web: www.ReedTech.com
www.ReedTech.com 36
Q&A
Please send questions
to “Staff” via webinar “Chat”
www.ReedTech.com 38
UDI Resources
FDA
UDI “Home Page”
• UDI Rule, GUID Guidance, Compliance Dates, Resources
• http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/default.htm
UDI Help Desk
• http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/ucm368904.htm
GUDID Information
• Basics, Guidance, Account Request, GUDID Web Interface, HL7 SPL, GUDID Status
• http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/GlobalUDIDatabaseGUDID/default.htm
GUDID Web Interface (Login)
• https://gudid.fda.gov/gudid/
CDRH Learn (FDA Presentations: GUDID overview, account setup, etc.)
• http://www.fda.gov/Training/CDRHLearn/ucm162015.htm#udi
IMDRF – www.imdrf.org
EC Medical Devices – http://ec.europa.eu/health/medical-devices
www.ReedTech.com 39
Medical Device UDI Glossary AIDC Automatic Id and Data Capture – technology used for automated product identification (typically 1D/2D
barcode, RFID, near-field communication, etc.)
DI Device Identifier – static product identification (uniquely identifies company and product version)
ESG Electronic Submissions Gateway – FDA agency-wide secure solution for accepting electronic regulatory submissions in electronic, bulk format
GUDID FDA Global UDI Database – registry of Medical Device DI and attributes
GS1 GS1 – an international, not-for-profit association that develops global standards (e.g., Global Trade Item Number-GTIN and Application Identifiers-AI) to improve the efficiency and visibility of supply and demand chains across sectors; www.gs1us.org
Issuing Agency FDA approved agency (standard) used to represent Medical Device UDI (GS1, HIBCC, and ICCBBA)
HIBCC Health Industry Business Communications Council – a non-profit organization that develops electronic exchange standards (e.g., Health Industry Bar Code-HIBC) for health care trading partners; www.hibcc.org
HL7 Health Level Seven – standards developing organization providing international healthcare information system interoperability standards for the exchange, integration, sharing, and retrieval of information
ICCBBA International Council for Commonality in Blood Banking Automation – international standards organization (not-for-profit, nongovernmental) responsible for the ISBT 128 Standard (International Standard for Blood and Transplant); www.iccbba.org
PI Production Identifier – dynamic manufacturing information (i.e. batch/lot #, serial #, mfg. date, expiration date, and HCT/P code)
SPL Structured Product Labeling – document markup standard (XML) approved by HL7 and adopted by FDA as a mechanism for exchanging product information
UDI Unique Device Identifier = Device Identifier (DI) + PI (Production Identifier) per approved Issuing Agency
XML Extensible Markup Language – markup language defining a set of rules for document encoding in both human and machine readable language.
