Prac4cal Approach to UDI Implementa4on

Transcription

1 Prac4cal Approach to UDI Implementa4on Carol Ryerson, Senior Principal Advisor September 23, 2015 Thank you for joining us! We will begin at Noon Central Time. Your phone line is currently muted. Regulatory and Clinical Research Ins4tute, Inc Wayzata Blvd., Suite 505 Minneapolis, MN USA rcri- inc.com

2 Prac4cal Approach to UDI Implementa4on Carol Ryerson, Senior Principal Advisor Your phone line has been muted. Type in any ques4ons you have in the Ques4ons box. Q&A will be at the end of the presenta4on. For technical difficul4es, please call Regulatory and Clinical Research Ins4tute, Inc Wayzata Blvd., Suite 505 Minneapolis, MN USA rcri- inc.com

3 Defining UDI Structuring the team Implemen4ng UDI Key Take Aways Q&A

4 What is Unique Device Iden4fica4on (UDI)? The FDA rule requires most medical devices distributed in the U.S. to: 1. Place bar- coded iden4fica4on and produc4on informa4on on the label. 2. Be registered in an FDA- operated database GUDID. 4

5 Implementa4on Dates: Device Implementa.on Date Direct Mark Requirements Class III (including class III LS/LS) Devices licensed under the PHS Act September 24, 2014 Class III LS/LS devices must be directly marked by Sept 24, 2015 All other Class III devices must be directly marked by Sept 24, 2016 Class II & I I/LS/LS September 24, 2015 N/A for implantables For LS/LS by Sept 24, 2015 Class II September 24, 2016 September 24, 2018 Class I, unclassified or not classified September 24, 2018 September 24, 2020 I/LS/LS implantable, life- suppor4ng or life- sustaining HDE Humanitarian Device Exemp4on PHS Act Public Health Service Act 5

6 Who Needs To Be Involved in UDI Compliance at My Company? 6

7 Product Iden4fica4on Data Flow Premarket Postmarket Design & Development Submissions/ elis.ng Manufacturing & Produc.on Sales/ Distribu.on Hospital/ Pa.ent Postmarket Surveillance H L 7 R P S H L 7 S P L H L 7 I C S R Unique Device Iden.fica.on emdr 510(k) PMA FURLS CECATS UDI Hospital ERP Registry 7

8 UDI Implementa4on Team Team members represen4ng the following key func4ons should be included: Regulatory Affairs Quality Assurance Labeling Supply Chain Procurement IT Marke4ng Legal 8

9 How to Navigate Selng Up UDI 9

10 What Do You Have To Do? 1. Establish a Master Implementa4on Plan and budget. 2. Select an Issuing Agency and set up a contract. 3. Determine the content of the barcode. 4. Figure out which labels will require UDI. 5. Establish the process to assemble GUDID elements for each device and packaging configura4on. 6. Determine if any supplier/ distribu4on agreements are affected by UDI compliance. 10

11 Selec4ng the UDI Issuing Agency The following are FDA accredited for UDI: GS1 Health Industry Business Communica4ons Council (HIBCC) ICCBBA Note: UDI terminology may differ by issuing agency 11

12 Selec4ng the Issuing Agency Select the agency that best fits your needs: Does your label already display a barcode? Are your products distributed to countries outside the U.S.? Will your customers require a par4cular barcode format? This is the 4me to move to a single standard on your product labels. 12

13 Using GS1 as Your Issuing Agency Connec4ng the FDA terminology with the established GS1 standard. Requirements of the UDI Rule with Corresponding GS1 Standards DI: Device Iden4fier PI: Produc4on Iden4fier Representa4on of UDI in AIDC Format Direct Marking UDI on Devices GUDID Data Submission (through HL7 SPL) GTIN: GS1 Global Trade Item Number Supplementary data elements, each indicated by an Applica4on Iden4fier (AI) GS1 Bar Codes GS1 Rules for Direct Part Marking GDSN: GS1 Data Synchroniza4on Network 13

14 Determine the Content of The Barcode 1. Assign a unique Device Iden4fier (DI) to each product SKU at the unit level and at each higher packaging level 2. Include a bar code on the label which: Encodes the DI and Encodes produc4on informa4on (PI), which may include: Batch/Lot Number Expira4on Manufacture Date Unique Serial number HCT/P iden4fica4on code per c Is accompanied by human- readable text of the bar code contents (even if redundant) 14

15 How GTINs are Assigned 15

16 Which Product Labels Require UDI? Each package level requires a separate DI to one level below Shipping Level. Note: Inves+ga+onal use only devices do not require UDI. 100 vials Box 1 Box 2 Box 3 Box 4 Case 1 Case 2 Case 3 Case 4 Case 5 Case 6 Unit Box Case Carton DI Required Pallet Shipping Level - no DI 16

17 Get Started with GUDID 1. Set up an account at AccessGUDID: 2. Download a copy of the GUDID Data Elements Reference Table. 17

18 Manage GUDID Elements Revise exis4ng procedures and/or create new procedures to collect and maintain GUDID data elements for all products and packaging levels. Consider merging exis4ng processes such as Device Lis4ng and informa4on for Trade Compliance. Ensure accuracy of data with appropriate valida4on. 18

19 GUDID Data Transfer Three op4ons for data transfer: Company FDA Company Product Master Manual entry FDA GUDID Database GUDID Web Interface Convert to HL7 Format Company Product Master FDA Electronic Submissions Gateway FDA GUDID Database GDSN Datapool Company Product Master FDA GUDID Database (1WorldSync, FSEnet, GHXExchange, ) 19

20 Key Deliverables Master Implementa4on Plan established Issuing Agency selected Barcode and label changes designed List of affected products is complete SOP to collect GUDID elements prepared and path for GUDID transfer determined 20

21 Implementa4on Next Steps: Test processes with a small number of products. Implement UDI for all products. Establish procedures to maintain UDI. 21

22 Before You Go.. RCRI Services UDI Overview for Execu4ve Management UDI Training for the Implementa4on Team Assist your UDI team with developing the implementa4on project plan Prac4cal sugges4ons for implemen4ng UDI 22

23 Ques4on and Answer Session 23

24 Carol Ryerson, Senior Principal Advisor inc.com Regulatory and Clinical Research Ins4tute, Inc Wayzata Boulevard, Suite 505 Minneapolis, MN rcri- inc.com 24