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2 Agenda Reed Tech Company Profile FDA UDI / GUDID Refresher 12 Steps for Accurate GUDID Submissions Reed Tech GUDID Submission Solution Overview Q&A 2

3 Questions Please send questions during the session to Staff via webinar Chat 3

4 Reed Tech Company Profile 4

5 Reed Tech Profile A recognized leader in providing solutions for content and lifecycle management Over 50 years of experience; founded in 1961 Part of the LexisNexis family; a business unit of Reed Elsevier Over 900 employees Contractor to USPTO to process all patent applications and grants Service Provider to over 800 Life Sciences companies, pharmaceutical and medical devices Philadelphia Headquarters Horsham, PA, USA Washington Operations Alexandria, VA, USA ISO Certified since 1998 (9001:2008) HL7 Member since 2005 GS1 Solution Partner 5

6 Reed Tech Pharma Services SPL Preparation, Submission, and Lifecycle Management for Drug Establishment Registration and Drug Product Labeling/Listing Service provider for over 800 pharma companies 4 of the 5 largest pharma manufacturers in the world; large (200+ labels) to small (1 label) Over 33,000 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 ESG WebTrader and AS2 connections Highest volume submitter of pharma SPLs (over 15,000) Over 450 companies Experts in CDER, CBER, and CVM Drug SPLs Data Transformation/Validation SPL Build, ESG Submission, and FDA Acknowledgement SPL Lifecycle Management SPL 6

7 Reed Tech Medical Device Services SPL Preparation, Submission, and Lifecycle Management for Medical Device product publication in FDA s GUDID GUDID solution provider for over 25 manufacturers (to date) 1 of the 3 largest Medical Device manufacturers in the world Submitted over 6,700 Class III SPL records to the GUDID (to date) 100% acceptance (comprehensive pre submission quality check) ~20% of total GUDID records (~33,000)* ~34% of total GUDID records via SPL (~20,000)* Current contracts to submit over 500,000 additional SPL records (to date) (Implantable/Life sustaining/life supporting, Class II, Class I) Experts in CDRH Medical Device UDI SPL Analysis, Data Aggregation/Transformation/Validation SPL Build, ESG Submission, and FDA Acknowledgement GUDID Data Life Cycle Management (SaaS and Outsourced model) SPL * Calculations based upon FDA statistics presented at Clarion UDI Conference, Baltimore, 28 Oct

8 Reed Tech Medical Device Services (continued) FDA Electronic Submissions Gateway (ESG) service Participated in FDA Pilot Submissions Program in 2014 to assist agency in high volume GUDID ESG load testing ESG AS2 connection for automated, bulk SPL submissions FDA Acknowledgment reporting GUDID Publication status (unpublished, grace period, published, off market) Global Roadmap Support customers needs for international UDID submissions as mandated Reed Tech System is designed to readily accommodate: Expanded data set of IMDRF and regional UDID attributes Building UDI submissions per regional specifications Submitting to international regulatory agencies 8

9 FDA UDI / GUDID Refresher Please send questions during the session to Staff via webinar Chat 9

10 FDA UDI Regulation Overview 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 ( ) 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 10

11 UDI on Label vs. GUDID Submission Data Definitions UDI = Device Identifier + Production Identifier(s) = DI + PI(s) GUDID Data = DI (not PI) + Device Attributes = 55 Submitted Fields 11

12 FDA UDI Compliance Timeline 12

13 Recent UDI Regulatory News FDA Advice to Industry FDA GUDID Guidance for Industry Structured input via the GUDID Web Interface requires manual data entry and is geared for low volume submitters. Health Level 7 (HL7) Structured Product Labeling (SPL) submission via the FDA Electronic Submissions Gateway (ESG) allows for submission via xml files and is geared for high volume submitters. Indira Konduri: Build data quality into all tenets of your process as you get organized for GUDID submission. FDA Industry Letter Dated FDA s experience and feedback from industry indicate that device labelers often take a number of actions related to organizing, collecting and validating data before they get a GUDID account or submit device identifier (DI) records. We strongly encourage all device labelers to take such actions to ensure their readiness to meet UDI requirements and streamline the GUDID submission process. FDA to accept GUDID account requests for I/LS/LS Labelers on (Class II later in 2015) FDA UDI Extensions Single Use Implants that are sterilized before use 1 year Label Extension to ; GUDID Submission date remains

14 12 Steps for Accurate GUDID Submissions Please send questions during the session to Staff via webinar Chat 14

15 Survey Results Your GUDID Submission Status What device classes does your organization manufacture (select all that apply)? (286 responses) How far along are you in identifying, collecting and organizing the UDI data that you will need to submit to the FDA GUDID? (286 responses) If you are submitting I/LS/LS UDI data to the FDA, and taking into consideration the September 24, 2015 deadline, when are you anticipating making your submissions? (268 responses) If you are submitting Class II UDI data to the FDA, and taking into consideration the September 24, 2016 deadline, when are you anticipating making your submissions? (239 responses) 15

16 12 Steps Summary UDI Prep 1. Create UDI Governance Team 2. Research/Identify FDA UDI Requirements for Your Products 3. Evaluate Your Situation 4. Define and Implement UDI Labeling Plan GUDID Prep 5. Evaluate, Select, and Implement GUDID Solution 6. Create FDA Accounts (GUDID, ESG) 7. Collect Source GUDID Data 8. Normalize and Validate Source GUDID Data Production 9. Submit GUDID Data to FDA 10. Process ACK Messages 11. Initiate & Maintain Data and System 12. International Readiness 16

17 Step 1 Create UDI Governance Team Product Design Label, DM Financial Mfg Funding, Budget UDI Label, DM Governance Marketing Publish, Order Mgmt Analysis, Planning, Roadmap Regulatory Production Control MDM, Inventory, Supply Chain Data is most likely in disparate systems Collect and Submit Data to FDA All data may not be in accessible electronic format 17

18 Step 2 Research/Identify FDA UDI Requirements for Your Products Research FDA UDI Final Rule and Guidance relevant to Your Products Identify your Product Class(es), Timing/Extensions, Exceptions, Direct Marking, etc. UDI Final Rule Final GUDID Guidance for Industry GUDID Data Elements Reference Table SPL Implementation Files Check UDI Activity in Industry Associations 18

19 Step 3 Evaluate Your Situation Evaluate your Data Situation Data location, gaps, owners, formats, etc. Evaluate Internal Standards Product Identification / Batch / Serialization Issuing Agency (GS1, HIBCC, or ICCBBA) for Product Identification UDI Formats by FDA Accredited Issuing Agency Evaluate Systems Existing MDM, Labeling System, etc. Existing AIDC Technology (1D, 2D, etc.) for UDI Presentation on Label Evaluate Processes Workflow Compliance Documentation Training 19

20 Step 4 Define and Implement UDI Labeling Plan Plan and Implement UDI Labeling (and Direct Marking) Process Revise Production Systems, e.g., MDM, ERP, PLM, Labeling, Inspection, Supply Chain Initiate Product / Batch / Serialization Identification Process Select and implement Issuing Agency (GS1, HIBCC, or ICCBBA) standard Assign Device Identifiers to Products (Primary, Secondary, Unit of Use, Direct Marking, Package Levels) Assign Production Identifiers to Batch / Lot / Serialization (ensure uniqueness) Implement AIDC Technology (1D, 2D, etc.) for UDI Presentation Revise Labels: add Human Readable UDI, AIDC UDI, and Dates to templates Ensure dynamic data flows from production system to product label If Direct Marking is required, redesign product label Perform necessary System Validation and Training Create necessary Documentation (DHF, SOPs, Work Instructions, etc.) 20

21 Step 5a Evaluate, Select, and Implement GUDID Solution 21

22 Step 5b Evaluate, Select, and Implement GUDID Solution Choose Submission Method 22 * SaaS Software as a Service

23 Step 5c Evaluate, Select, and Implement GUDID Solution Submission Method 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 Limited international reuse No software cost Your admin, data entry, & QA labor 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 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 23 Rent software No internal Admin & operations labor Service cost

24 Step 5d Evaluate, Select, and Implement GUDID Solution Select and Implement Method Selection Considerations Solution Capabilities, Expertise, and Experience SPL Data Validation Controlled Vocabularies FDA ESG Submission ACK Processing and Reporting On going Data Management (ease and capability) Future Proof Scalable International capabilities 21 CFR Part 11 Compliance (not relevant for FDA GUDID Web Interface) Cost Effective Implement Chosen Solution 24

25 Survey Results Your GUDID Solution Preferences Have you decided what method you will use to submit your UDI data to the GUDID? (274 responses) If yes, which of the following methods do you prefer? (224 responses) 25

26 Step 6a Create FDA Accounts (GUDID, ESG) Request GUDID Account Form GUDID Pre Production Account Set Up Process Request a Pre Production (Test) GUDID Account Request Form from the FDA aludidatabasegudid/default.htm#account 26

27 Step 6b Create FDA Accounts (GUDID, ESG) Complete and Submit GUDID Account Form GUDID Pre Production Account Set Up Process Complete the GUDID Account Request Form (Identify Labeler DUNS Numbers / Users / Roles) Attachment to from the FDA (top half of page 1; 3 pages total) 27

28 Step 6c Create FDA Accounts (GUDID, ESG) Setup ESG Account 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 Note: Reed Tech provides ESG account setup and ESG submission as part of our service at no additional charge 28

29 Step 6d Create FDA Accounts (GUDID, ESG) Test GUDID Pre Production Account using ESG Connection GUDID Pre Production Account Testing Process (if using SPL Submissions) Complete 4 Test Scenarios SPL submission into GUDID obaludidatabasegudid/ucm zip 29 Note: Reed Tech provides SPL Test submissions using our ESG AS2 connection at no additional charge

30 Step 6e Create FDA Accounts (GUDID, ESG) Setup GUDID Production Account GUDID Production Account Set Up Process Request a Production GUDID Account using the same process as the Pre production account Use the same Application Form as before; make any changes necessary for the GUDID Production environment 30

31 Step 7a Collect Source GUDID Data Collect Source Production GUDID data Collect data from multiple sources, such as: Production Systems, e.g., PLM, MDM, ERP Labeling System (label templates, dynamic data) Regulatory Systems If necessary, capture data from Label (e.g., single use icon) Populate (55) GUDID Values into Records Reed Tech GUDID Data Template is available to organize content Merge partial records from multiple data sources If desired, collect additional data fields for your internal purposes and/or future UDI submissions to international Regulatory Authorities 31

32 Step 7b Collect Source GUDID Data GUDID Data (directly) GUDID Data (needs coding) 32 Reference: FDA GUDID GFI Jun

33 Step 7c Collect Source GUDID Data ( 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 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) 55 Submitted by Labeler 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) (some can have multiple values) 7 Populated by FDA GUDID System 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 33

34 Step 8a Normalize & Validate Source GUDID Data Normalize data to FDA GUDID specs Follow FDA Business Rules. For example: GS1 GTINs must be 14 numeric characters Date Format must be YYYY MM DD Where applicable, ensure values utilize Controlled Vocabularies. For example: cm for Size Unit of Measure Cel for Temperature (Degrees Celsius) For grouped data, all necessary related fields must be populated. For example: Clinically Relevant Size Type = Length Clinically Relevant Size Value = 25 Clinically Relevant Size Unit = cm For dependent data, all necessary related fields must be populated. For example: If Require Sterilization prior to use? = Yes, then Sterilization Method must be populated Validation of all content: the key to accuracy for your SPL submissions to the FDA Problematic Data Elements from our experience. For example: Labeler DUNS Numbers Device Identifiers assignment GMDN or FDA Preferred Term Values Packaging and Kit Configurations Data Validation is a Reed Tech core competency we can help 34

35 Step 8b Normalize & Validate Source GUDID Data (available upon request) 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) 35

36 Step 9 Submit GUDID Data to FDA Go Live Submit Production device records For Manual, Individual Record Entry: Enter data via FDA GUDID Web Interface Perform QC on Data Entry For Automated, Bulk Entry: Create fully valid SPL UDI submissions per FDA business rules Validate SPL XML per FDA schema requirements Submit SPL UDIs to FDA via ESG WebTrader record by record manually driven process AS2 (Applicability Statement 2) communication protocol for automated bulk transfer SPL Validation and ESG Submission are Reed Tech core competencies we can help 36

37 Step 10 Process ACK Messages Applicable to SPL Submissions only Monitor and Collect FDA ACK messages ACK 1 FDA receipt confirmation ACK 2 CDRH receipt confirmation ACK 3 CDRH validation results Pass Fail, explanatory error message provided Report ACKs Indicate GUDID Record Publication Status Unpublished Published, in Grace Period Published Retired (product taken off market) 37

38 Step 11 Initiate & Maintain Data and System Start Manufacturing Confirm Device Record is Published in GUDID Cutover process to include UDI on Label (with direct marking where applicable) Manage existing Inventory within 3 year allowed window Flow DI and PI from production systems to labels Data Maintenance Update/retire Device Labels and GUDID records as appropriate Add Device Labels and GUDID records for new products System Maintenance (for in house software only) Update, Validate, Train, and Document system changes Knowledge Maintenance Monitor and Implement changing FDA Regulations and Guidance (subscribe to FDA UDI/GUDID notifications) 38

39 Step 12 International Readiness International Medical Devices Regulatory Forum (IMDRF) Cornerstone of global medical device regulatory direction Group of Medical Device Regulators (Australia, Brazil, Canada, China, EU, Japan, Russia, U.S.) A single worldwide UDID will not be implemented Per Laurent Selles, Senior Coordinator for International Relations, EC; Munich, May 2014 Regional UDIDs will contain core information and have varying regional content. Convergence, not Harmonization EU Late 2015 / most likely 2016 EU UDI Mandate Other regulatory authorities actively involved in UDI EU Asia (China, Japan, Korea, Singapore) Australia Canada South America (Brazil, Argentina) 39

40 Reed Tech LSP GUDID Submission Solution (SaaS or Outsourced) Please send questions during the session to Staff via webinar Chat 40

41 Reed Tech GUDID SPL Solution (SaaS or Outsourced) 41

42 Reed Tech UDI Solution Benefits Simple Complements your current internal processes SaaS and Outsourced both available Minimally intrusive Accepts data from your existing systems, initially and for subsequent, on going maintenance Flexible data import options: XLS, XML, text file, manual entry Save Time Reed Tech Life Science Portal can help save time during the data collection process Data Transformations per Reed Tech Synonym Vocabulary Data Aggregation Data Collection Assistance available Cost effective Efficient, automated, bulk submissions Save IT costs (e.g., hardware/software purchase, installation, validation, maintenance) 42

43 Reed Tech UDI Solution Benefits (continued) Flexible, Scalable and Future Architected GUDID solution Accommodates additional custom/proprietary data fields beyond FDA requirements Easy expansion for future UDID submissions to global regulatory authorities (EC, PMDA ) Secure, Validated System Secure, environmentally controlled data center System meets all 21 CFR Part 11 technical compliance standards Role based data management and approvals Preparation, submission, and acknowledgement reporting E signature submission approval Gain an experienced corporate partner Over 50 years of knowledge and expertise in data collection, content conversion and validation, submissions, lifecycle management, and excellent customer service 43

44 Reed Tech UDI Resources Available from ReedTech.com: GUDID Readiness Kit free ebook udi readiness kit Reed Tech GUDID Data Element List elements Multiple Options To Weigh For Moving A UDI Into FDA s Database The Gray Sheet 6 January sheet article 0 UDI Training Course (in collaboration with Lernia Training Solutions) Available Upon Request: Sample GUDID Account Request Form Reed Tech GUDID Record Template 44

45 Reed Tech Contact Information Haley Lentz Account Executive, Life Sciences Phone: or Web:

46 Q&A Please send questions to Staff via webinar Chat 46

47 Reference Material 47

48 UDI Resources FDA UDI Home Page UDI Rule, GUID Guidance, Compliance Dates, Resources ntification/default.htm UDI Help Desk ntification/ucm htm GUDID Information Basics, Guidance, Account Request, GUDID Web Interface, HL7 SPL, GUDID Status ntification/globaludidatabasegudid/default.htm GUDID Web Interface (Login) CDRH Resources (FDA Presentations: GUDID overview, account setup, etc.) tification/changesbetweenudiproposedandfinalrules/default.htm IMDRF EC Medical Devices devices 48

49 Medical Device UDI Glossary AIDC DI ESG GUDID GS1 Automatic Id and Data Capture technology used for automated product identification (typically 1D/2D barcode, RFID, near field communication, etc.) Device Identifier static product identification (uniquely identifies company and product version) Electronic Submissions Gateway FDA agency wide secure solution for accepting electronic regulatory submissions in electronic, bulk format FDA Global UDI Database registry of Medical Device DI and attributes 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; 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; HL7 ICCBBA PI SPL UDI XML Health Level Seven standards developing organization providing international healthcare information system interoperability standards for the exchange, integration, sharing, and retrieval of information 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); Production Identifier dynamic manufacturing information (i.e. batch/lot #, serial #, mfg. date, expiration date, and HCT/P code) Structured Product Labeling document markup standard (XML) approved by HL7 and adopted by FDA as a mechanism for exchanging product information Unique Device Identifier = Device Identifier (DI) + PI (Production Identifier) per approved Issuing Agency Extensible Markup Language markup language defining a set of rules for document encoding in both human and machine readable language. 49

50 Global (G)UDID Data Elements 50