Submitting to the GUDID: Labeler s Lessons Learned Panel Discussion

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Leslie Osborne
5 years ago
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1 Submitting to the GUDID: Labeler s Lessons Learned Panel Discussion 25 June 2015 Slide 1

2 Boston Scientific - Dawn Stenstrom What Has Worked Well UDI Requirements: Core team structure and Regulatory UDI SME team Detailed regulatory plan Procedures and work instructions: UDI and conforming amendments Labeling: Leverage existing labeling system and governance structure GUDID: Data element mapping: definition, source data, responsibility Data review and approval process Slide 2

3 Boston Scientific - Dawn Stenstrom Lessons Learned Brace Yourself for Change/Challenges: GUDID changes, source data challenges Training: database users, impacted function Labeling: If you are changing or adding your UDI Communicate to your customers up front Identify a plan to address customer s supply chain scanning process/system questions Mergers/Acquisitions: Coordination with FDA and labeling transition plan GUDID system constraints to maintain UDI compliance and enable the least amount of impact to your customer Slide 3

4 Stryker Amy Delk What s worked well Cross functional global team with clear leads and company-wide/site responsibilities UDI makes good business sense this is more than compliance Clearly defining the data elements within Stryker Slide 4

5 Stryker Amy Delk Lessons Learned M&A pathway not always clear DM for configurable capital equipment Control of the data once gathered Ensuring OEM device data is available to customers Understanding your supply chain network Slide 5

6 Medtronic Tania Pearson Regulatory Process SME for UDI Corporate Regulatory point person for UDI data conversion Coordinate development and delivery of training Primary Regulatory contact for end to end UDI Submission process UDI Change Advisory Board Chairperson Drive identification of Polices and Procedure updates as needed Slide 6

7 Medtronic Tania Pearson Past: Used UDI as foundation for Regulatory Information Management (RIM) Submitted Class III (completed September 23, 2014). Present: Currently submitting FDASIA (started June 8, 2015). Developing process UDI submissions for acquisitions (Covidien). Future: Enhancements to Internal Systems needed for Class II materials. Future UDI Requirements. Slide 7

8 Napoleon Monroe - Dental Industry PRODUCTS Small size of oral cavity, small products, small offices. Many low risk devices, high number of skus, and many sterile and reusable devices. Marking and labeling requirements. True implants and many items which remain in the mouth for 30 days. List of "implantable... devices." UDI timing. Cosmetic emphasis. Some direct product marking exempted. Pharma as well as devices. High utilization of tissues of human origin. Slide 8

9 Napoleon Monroe - Dental Industry COMPANIES Somewhat unlike panel colleagues. Many Small and medium size enterprises (SMEs). Maybe like audience. Distributors, manufacturers, practice management software and consultants. Private branding and contract manufacture. Betond dental into medical and even vet. SMEs and individual practitioners still have a significant place in the industry. Slide 9

10 Napoleon Monroe - Dental Industry ENVIRONMENT Access to care, cost, reimbursement and structural issues. Far less benefit from ACA. ADA, NDA and specialty dental organizations rather than AHA and AMA set standards and influence practice. Dental Trade Alliance provides liaison with stakeholders. Slide 10

11 Submitting to the GUDID: Labeler s Lessons Learned Panel Facilitator: Dawn Stenstrom, Sr. Manager, Global Regulatory Affairs Boston Scientific Panelists: Nada Savatic, Senior Program Manager, Abbott Amy Delk, Director, Regulatory Affairs, Stryker Tania Pearson, Principal Regulatory Operation Specialist, Medtronic, Inc. Napoleon Monroe, Consultant to Dental Trade Alliance (DTA) Slide 11

Implementation of UDI In the Medical Device Industry

Implementation of UDI In the Medical Device Industry IMDRF UDI Workshop - Brussels, Belgium Monday, 12 February 2018 Jackie Rae Elkin - Global Medical Technology Alliance (GMTA) James Turner - Global Diagnostic