1. FDA-CDRH in the Next Decade A Vision for Change
William H. Maisel, MD, MPH
Deputy Director for Science and Chief Scientist
Director Office of Device Evaluation (Acting)
Center for Devices and Radiological Health

2. Disclosure Statement of Financial Interest
I, William Maisel, DO NOT have a financial interest/arrangement or affiliation with one or more organizations that could be perceived as a real or apparent conflict of interest in the context of the subject of this presentation.
William H. Maisel, MD, MPH – CRT 2015

3. William H. Maisel, MD, MPH – CRT 2015
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.
Vision
William H. Maisel, MD, MPH – CRT 2015

4. William H. Maisel, MD, MPH – CRT 2015
Its About the Patients
William H. Maisel, MD, MPH – CRT 2015

5. CDRH 2014-2015 Strategic Priorities
Strengthen the Clinical Trial Enterprise in the US
Strike the Right Balance Between Premarket and Postmarket Data Collection
Provide Excellent Customer Service
William H. Maisel, MD, MPH – CRT 2015

6. Strengthen the Clinical Trial Enterprise
Clinical Trials Program
Early Feasibility First in Human Policies
Benefit-Risk Determinations
IDE Decisions Guidance
Implemented FDASIA
William H. Maisel, MD, MPH – CRT 2015

7. Strengthen the Clinical Trial Enterprise
CDRH FY 2015 Target: Reduce overall median time to
full appropriate IDE approval to 30 days
Median Time to Full Appropriate IDE Approval
DAYS
William H. Maisel, MD, MPH – CRT 2015

8. CDRH 2014-2015 Strategic Priority
Strike the Right Balance Between Premarket and Postmarket Data Collection
Goal: Assure the appropriate balance between premarket and postmarket data requirements to facilitate and expedite the development and review of medical devices, in particular high-risk devices of public health importance.
William H. Maisel, MD, MPH – CRT 2015

9. William H. Maisel, MD, MPH – CRT 2015
Strike the Right Balance Between Premarket and Postmarket Data Collection
Benefit-Risk Framework
Pre-Post Balance
Expedited Access PMA
Patient Preferences
Retrospective PMA Review
Modernize
Postmarket Surveillance
William H. Maisel, MD, MPH – CRT 2015

10. Benefit-Risk Framework
Guidance
Factors to Consider for Benefit-Risk Determinations
(Medical Device Premarket Approval and De Novo Classification)
Type, Magnitude, and Duration of Benefits and Risks
Availability of Alternative Treatments
Severity of Disease
Uncertainty
Patient Tolerance for Risk and Perspective on Benefit
William H. Maisel, MD, MPH – CRT 2015

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

12. Expedited Access PMA (EAP) William H. Maisel, MD, MPH – CRT 2015
Draft Guidance – April 2014
Goal: Help get patients more timely access to medical devices that address:
Unmet Medical Needs
Life Threatening or Irreversibly Debilitating Diseases or Conditions
Proposal:
Collaborative engagement with device developer
Data development plan
Case manager assigned, if and when, appropriate
Some premarket data shifted to postmarket setting
Plan: Finalize Guidance and Implement in FY 2015
William H. Maisel, MD, MPH – CRT 2015

13. William H. Maisel, MD, MPH – CRT 2015

14. William H. Maisel, MD, MPH – CRT 2015
Strike the Right Balance Between Premarket and Postmarket Data Collection
Retrospective Review of all PMA Types
Determine whether or not to shift some premarket data requirements to the postmarket setting or to down classify device types in light of our current understanding of the technology.
CDRH Targets: - Review 50 percent of all PMA device types by December 2014
- Complete Review by December 2015
William H. Maisel, MD, MPH – CRT 2015

15. Premarket-Postmarket Balance Evolving Use of Registries
Postmarket Surveillance
Leverage Infrastructure for Premarket Studies
“Real World” Use to Support Expanded Indications
Link to Other Databases -EHR, Claims, etc.
Useful to Multiple Stakeholders
William H. Maisel, MD, MPH – CRT 2015

16. Unique Device Identifier Implementation
Date
UDI Implementation
September 24, 2014
Class III devices
September 24, 2015
Implantable, life-supporting and life-sustaining devices
September 24, 2016
Class II devices
September 24, 2018
Class I devices
Devices not classified into Class I, II or III
UDI System
William H. Maisel, MD, MPH – CRT 2015

17. 84% Provide Excellent Customer Service CDRH Targets: FY 2014 - 70%
Customer Satisfaction
Customer Service Standards of Excellence
Customer Service Survey
FEEDBACKCDRH
CDRH Quality Management Framework
CDRH Targets:
FY %
December 2015 – 90%
William H. Maisel, MD, MPH – CRT 2015

18. Keys to Timely Premarket Approval
Strengthen the Clinical Trial Enterprise
Strike the Right Premarket-Postmarket Balance
Weigh Benefits and Risks
Consider Patient Perspectives
Provide Excellent Customer Service
Collaborate with Stakeholders
William H. Maisel, MD, MPH – CRT 2015

19. FDA-CDRH in the Next Decade A Vision for Change
William H. Maisel, MD, MPH
Deputy Director for Science and Chief Scientist
Director Office of Device Evaluation (Acting)
Center for Devices and Radiological Health