1. Premarket Review Performance Goals Donna-Bea Tillman Director, Office of Device Evaluation Director, Office of Device Evaluation Don St. Pierre Deputy Director, Office of In Vitro Diagnostic Device Evaluation and Safety MDUFMA Stakeholder Meeting November 18, 2004

2. MDUFMA’s Promise FDA will turn dollars into shorter review times. FDA will turn dollars into shorter review times.

3. Meeting the MDUFMA goals while maintaining our commitment to good science. Meeting the MDUFMA goals while maintaining our commitment to good science. MDUFMA’s Challenge

4. How are we making this happen?

5. Office of Device Evaluation Office of Surveillance Surveillance & Biometrics Office of Science & Engineering Laboratories OfficeofCompliance Office of Communication, Education, and Radiation Programs Office of In Vitro Diagnostic Device Evaluation and Safety Office of Management Operations New Vision of Pre-Market Review

6. What are we doing to foster this vision? Shared hires Shared hires eRoom eRoom eConsults eConsults Shared agreement on timelines….. Shared agreement on timelines….. -> Shared commitment to the goals

7. How are we spending your money?

8. Hiring!

9. Light Blue -- Other MDUFMA Review Process FTEs: Adverse Exp. Reporting, Lab Based Studies, Problem ID Resolution, Science Based Training, Domestic Standards, and Postmarket Studies. Red -- Premarket FTEs: Application Review, Guidance and Standards, Bioresearch monitoring and Manufacturers assistance. CDRH Device Review Process FTEs

10. 9 28 45 8 12 15 1 CDRH Device Review FTEs by Category

11. Physicians* - 15 Physicians* - 15 Visiting Scholar – senior level clinicians, surgeons Visiting Scholar – senior level clinicians, surgeons Fellow - physician during fellowship training Fellow - physician during fellowship training Resident – physician during residency training Resident – physician during residency training Engineers* - 42 Engineers* - 42 Visiting Scholar – senior level engineer Visiting Scholar – senior level engineer Co-op students Co-op students Interns Interns Physicists* - 2 Physicists* - 2 Scientists* - 5 Scientists* - 5 *includes students Medical Device Fellowship Program (FY04)

12. All those new hires need to be trained All those new hires need to be trained The good news: training for new recruits improved their proficiency The good news: training for new recruits improved their proficiency The bad news: training for new recruits took a lot of resources and is not complete. The bad news: training for new recruits took a lot of resources and is not complete. We also need to maintain the skills of existing staff We also need to maintain the skills of existing staff Training!

13. Improved IT infrastructure! Current IT needs Current IT needs Tracking Tracking Reviewing Reviewing Collaborating Collaborating Managing correspondence Managing correspondence Archiving - Image Archiving - Image Electronic Review? And maybe one day…. And maybe one day….

14. Just the Numbers For complete report, please see: http://www.fda.gov/cdrh/mdufma/presentations/102004-kahan.ppt

15. Status of FY03 PMA/O & PT-PMA/S receipt cohort Complete In Process (August 18, 2004) 100% of those with final decisions completed in < 320 days

16. CDRH PMA Performance FY 2003 Receipt Cohort as of 9/30/2004 47 Original PMAs and P-T Supplements filed 47 Original PMAs and P-T Supplements filed 41 FDA decisions; 6 pending applications 41 FDA decisions; 6 pending applications % of decisions meeting goal: 95% % of decisions meeting goal: 95% % of cohort meeting goal (to date): 83% % of cohort meeting goal (to date): 83% % awaiting MDUFMA decision: 13% % awaiting MDUFMA decision: 13% FY 2006 Goal: 80% of FDA decisions within 320 FDA days (Decision = approval, approvable, approvable pending GMP, not approvable, denial) (Decision = approval, approvable, approvable pending GMP, not approvable, denial)

17. CDRH PMA Performance FY 2003 Receipt Cohort as of 9/30/2004 25 1 st action = major deficiency letter 25 1 st action = major deficiency letter % of actions meeting goal: 84% % of actions meeting goal: 84% FY 2005 Goal: 75% within 150 FDA days 22 “all other” 1 st actions 22 “all other” 1 st actions % actions meeting goal: 96% % actions meeting goal: 96% FY 2005 Goal: 75% 180 FDA days FY 2003 first action cohort is closed FY 2003 first action cohort is closed

18. Status of FY04 PMA/O & PT-PMA/S receipt cohort Complete In Process (August 18, 2004) 100% of those with final decisions completed in < 320 days

19. CDRH PMA Performance FY 2004 Receipt Cohort as of 9/30/2004 41 Original PMAs and P-T Supplements filed 41 Original PMAs and P-T Supplements filed 11 FDA decisions; 30 pending applications 11 FDA decisions; 30 pending applications % of decisions meeting goal: 100% % of decisions meeting goal: 100% % of cohort meeting goal (to date): 27% % of cohort meeting goal (to date): 27% % awaiting MDUFMA decision: 73% % awaiting MDUFMA decision: 73% FY 2006 Goal: 80% of FDA decisions within 320 FDA days (Decision = approval, approvable, approvable pending GMP, not approvable, denial) (Decision = approval, approvable, approvable pending GMP, not approvable, denial)

20. CDRH PMA Performance FY 2004 Receipt Cohort as of 9/30/2004 20 1 st action = major deficiency letter 20 1 st action = major deficiency letter % of actions meeting goal: 85% % of actions meeting goal: 85% FY 2005 Goal: 75% within 150 FDA days 12 “all other” 1 st actions 12 “all other” 1 st actions % actions meeting goal: 100% % actions meeting goal: 100% FY 2005 Goal: 75% 180 FDA days 9 with first action pending (22% of cohort) 9 with first action pending (22% of cohort)

21. Improving PMA performance Goal: Shorten both cycle and total decision times Goal: Shorten both cycle and total decision times … which will improve predictability and decrease time-to-market.

22. Original PMA Milestones: 1-cycle Scenario Filing Review Scientific Review Panel Planning Closeout Review PMA Received` Panel Go/NoGo Panel Meeting Filing Letter Final Decision 180 days Status Letter Consults Complete Interactive Review

23. Original PMA Milestones: 2-cycle Scenario Filing Rev Scientific Review Panel Planning Closeout Review PMA Received Panel Go/NoGo Panel Meeting Filing Letter Final Decision 320 days Major Def. Letter Scientific Review Clock Stops Staus Letter Interactive Review Consults Complete

24. 510k Goals

25. FY03 510k Performance FY03 Performance FY05 Goal Final decision <90 days 76%75% First action <75 days 58%70% Second action < 60 days 50%70% Need to improve performance on cycle goals

26. Meeting the MDUFMA goals: Review Process for Traditional 510ks Preliminary determination that no significant additional info needed FDA Initial ReviewInteractive Review Final Decision (<90 total days) Scenario #1

27. Meeting the MDUFMA goals: Review Process for Traditional 510ks FDA Initial ReviewInteractive Review Determination that significant additional info needed Hold Final Decision (<90 total days) Scenario #2 Preliminary determination that no significant additional info needed

28. Meeting the MDUFMA goals: Review Process for Traditional 510ks FDA Initial Review Review Determination that significant additional info needed Hold Final Decision (<90 total days) Scenario #3 Hold Review Determination that significant additional info needed

29. Preliminary FY04 510k Performance FY04 Performance FY05 Goal Final decision <90 days 89%75% First action <75 days 78%70% Second action < 60 days 81%70% Preliminary data suggests improvement in performance on cycle goals 29% of cohort awaiting final decision as of 9/30/04

30. What about the Science?

31. Program to Assess Quality of Premarket Reviews Focuses on selected cross-cutting areas (e.g., biocompatibility) Focuses on selected cross-cutting areas (e.g., biocompatibility) Retrospective (post-decision) peer assessments of sampled reviews Retrospective (post-decision) peer assessments of sampled reviews Quality assessment teams with defined criteria Quality assessment teams with defined criteria Pilot underway Pilot underway

32. Where have we been? We’ve made progress in meeting the goals, but it has come at a price.

33. The price of early success Our staff are working at the limits of their abilities Our staff are working at the limits of their abilities “Luxuries” such as training, standards, and guidance development have been neglected “Luxuries” such as training, standards, and guidance development have been neglected

34. Where are we now? We’ll continue to improve performance, but there are additional challenges ahead.

35. The number of combination products is growing… Coronary Stent Pacing Lead Bone graft … necessitating new kinds of technical expertise and new regulatory paradigms.

36. The number of 510ks with clinical data is growing… Embolic protection devices … requiring more in-depth review, including occasional Panel input. Vascular anastomsis devices for CABG Image-guided bronchoscopes Barbed sutures Glaucoma shunts Daily wear contact lenses CPAP devices for apnea

37. The number of expedited submissions is growing…. expedited PMAs in FYO4 vs. 3 expedited PMAs in FYO3 14 … shortening timeframes and bringing increasingly complex scientific questions.

38. Where are we going? The best is yet to come!

39. Systematic management of timeframes Systematic management of timeframes Improvements to IT infrastructure Improvements to IT infrastructure Well-trained staff Well-trained staff More guidance documents More guidance documents Open communication Open communication Strategies for Meeting Beating the MDUFMA Goals

40. The REAL promise of MDUFMA More interaction More interaction Stronger science Stronger science Greater predictability Greater predictability Better public health Better public health

41. …and a continuing commitment to Least Burdensome Principles

42. Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) Turbo 510(k) Pilot Turbo 510(k) Pilot Software/program development Software/program development Pre-IDEs Pre-IDEs Number/interactions increasing Number/interactions increasing Decision Summaries Decision Summaries Public/information sharing Public/information sharing Webpage Re-design in process Webpage Re-design in process Based on your feedback Based on your feedback Internal training (challenging the status quo) Internal training (challenging the status quo) Stressing TPLC, Communication, Collaboration Stressing TPLC, Communication, Collaboration

43. Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) Also, Proactive in: Also, Proactive in: Bioterrorism activities to improve development and access to rapid diagnostics Bioterrorism activities to improve development and access to rapid diagnostics CLIA improvements (including development of waiver criteria, program development) CLIA improvements (including development of waiver criteria, program development) Pharmacogenomics Pharmacogenomics

44. MDUFMA Questions?