FDA’s Medical Device Program 2013: Looking Back and Looking Ahead

1. FDA’s Medical Device Program 2013: Looking Back and Looking Ahead Jeffrey Shuren, M.D., J.D. Center for Devices and Radiological Health U.S. Food and Drug Administration August 27, 2013

2. Overview • CDRH’s Vision • Premarket Programs • Postmarket Surveillance • Regulatory Science • International Convergence

3. Vision Patients in the U.S. have access to high-quality, safe, and effective medical devices of public health importance first in the world. The U.S. is the world’s leader in regulatory science, medical device innovation and manufacturing, and radiation-emitting product safety. U.S. post-market surveillance quickly identifies poorly performing devices, accurately characterizes real-world performance, and facilitates device approval or clearance. Devices are legally marketed in the U.S. and remain safe, effective, and of high-quality. Consumers, patients, their caregivers, and providers have access to understandable science-based information about medical devices and use this information to make health care decisions. 3

4. Premarket Program Improvements

5. 2001-2013

6. 510(k)s

7. Percent of 510(k)s with Additional Information (AI) Request on 1st FDA Review Cycle

8. Percent of 510(k)s with Additional Information (AI) Request on 1st FDA Review Cycle *FY 2013 data are based on the first substantive review cycle, i.e., excluding RTA cycles

9. Average Time to Decision: 510(k)s*(Receipt Cohorts as of June 30, 2013) *SE and NSE decisions only; times may not add to total due to rounding

10. Average Time to Decision: 510(k)s*- Comparison of Receipt Cohorts When 96.2% Closed - *SE and NSE decisions only; times may not add to total due to rounding

11. 510(k) Receipts and Decisions 11

12. Trend in 510(k) Tier 1 Goal Performance- Comparison of FY09 - FY12 Receipt Cohorts - 12

13. 510(k)s Pending* at End of Year * Under review or on hold

14. 510(k)s Pending* at End of Year * Under review or on hold ** FY 2013 is as of 06/30/2013 and excludes FY 2013 receipts that have not been accepted for substantive review

15. Percent of 510(k)s Determined to be Substantially Equivalent (SE)

16. Percent of 510(k)s Determined to be Substantially Equivalent (SE)

17. PMAs

18. Percent of PMAs With Major Deficiency Letter (MAJR) on 1st FDA Review Cycle* *Includes all filed original PMAs (1st cycle completed for all cohorts)

19. Percent of PMAs With Major Deficiency Letter (MAJR) on 1st FDA Review Cycle* *Includes all filed original PMAs (1st cycle completed for all cohorts)

20. Average Time to MDUFA Decision: PMAs*(Filed Cohorts as of June 30, 2013) *Includes all filed original PMAs; times may not add to total due to rounding **Cohorts still open, average times will increase; percent of cohort with MDUFA decision: FY10 = 98% (42/43); FY11 = 95% (41/43); FY12 = 83% (20/24)

21. Average Time to MDUFA Decision: PMAs*- Comparison of Filed Cohorts When Approx. 83% Closed** - *Includes all filed original PMAs; times may not add to total due to rounding **Proportion of cohort closed (MDUFA decision): FY07 = 29/35; FY08 = 25/30; FY09 = 27/32; FY10 = 36/43; FY11 = 36/43; FY12 = 20/24

22. PMAs Pending* at End of Year *All original PMAs under review or on hold

23. PMAs Pending* at End of Year *All original PMAs under review or on hold **FY 2013 is as of 06/30/2013 and excludes FY 2013 receipts that have not been accepted for substantive review

24. Percent of PMAs Approved* *Based on original PMAs that were accepted for filing

25. Percent of PMAs Approved* *Based on original PMAs that were accepted for filing

26. Looking Ahead

27. Premarket Programs

28. Key Pre-Market Actions in 2013 Implement the Food and Drug Administration Safety and Innovation Act (FDASIA) MDUFA III Performance Goals Guidances: Pre-Submission Meetings, Refuse-to-Accept/Refuse-to-File Criteria, eCopy, Benefit-Risk Determinations De Novo Issue guidances under the Plan of Action to Improve the Medical Device Pre-Market Program Early Feasibility IDE Approvals Implement Network of Experts and Experiential Learning Program 28

29. Entrepreneurs in Residence 2013 Projects Reducing the time and cost of clinical trials while maintaining patient protection Streamlining the pathway from FDA approval to payer coverage Striking the right balance between premarket and postmarket evidentiary requirements 29

30. National Medical Device Postmarket Surveillance System 30

31. National Medical Device Post-Market Surveillance System • Draft strategy issued September 2012 http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHReports/ucm301912.htm • Establish a Unique Device Identification System and Promote Its Incorporation into Electronic Health Information • Promote the Development of National and International Device Registries for Selected Products • Modernize Adverse Event Reporting and Analysis • Develop and Use New Methods for Evidence Generation, Synthesis and Appraisal • 4-Days public meeting held September 10-13, 2012 31

32. National Medical Device Post-Market Surveillance System

33. National Medical Device Post-Market Surveillance System • April 2013 Update and Next Steps Report • Establish a multi-stakeholder planning board • Governance structure, policies, procedures, business models • Finalize the UDI rule • Establish a registry task force under MDEpiNet • Identify and leverage existing registries • Identify priority device type for registry consideration • Define registry governance and data quality practices • Develop strategies for use of registries to support pre-market approval and clearance • Pilot an initial functional release of the FDA Adverse Event Reporting System (replacement for MAUDE) 33

34. Regulatory Science

35. What is Regulatory Science? • Provides the tools, standards, and approaches needed to evaluate the safety, effectiveness, performance, and quality of medical products • Benefits patients by speeding the rate of important technologies reaching market • Reduces time and resources needed for device development, assessment, and review. For example: • Can lead to quicker, more efficient device approvals • Can decrease the size and duration of pre-market clinical trials 35

36. Medical Device Innovation Consortium Public-Private Partnership with LifeScience Alley Allows for the pooling and sharing of propriety data, funding and expertise in the pre-competitive space Creates an ongoing mechanism to support advances in regulatory science Incorporates a process to validate and qualify new regulatory science tools 36

37. Medical Device Innovation Consortium 29 Members 3 Initial Project Areas Clinical Trial Reform Benefit-Risk Guidance and Patient Centeredness Computer Modeling New members joining 37

38. International Convergence 38

39. International Medical Device Regulators Forum Participants Australia, Brazil, Canada, China, EU, Japan, US are members WHO is an official observer Asian Harmonization Working Party is an affiliate Work Items Medical Device Single Audit Program Regulatory Product Submission Unique Device Identification Systems Standalone Medical Device Software 39

40. Vision Patients in the U.S. have access to high-quality, safe, and effective medical devices of public health importance first in the world. The U.S. is the world’s leader in regulatory science, medical device innovation and manufacturing, and radiation-emitting product safety. U.S. post-market surveillance quickly identifies poorly performing devices, accurately characterizes real-world performance, and facilitates device approval or clearance. Devices are legally marketed in the U.S. and remain safe, effective, and of high-quality. Consumers, patients, their caregivers, and providers have access to understandable science-based information about medical devices and use this information to make health care decisions. 40