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

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

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

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

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

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

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

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

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

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

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

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

William H. Maisel, MD, MPH – CRT 2015

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

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

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

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 2014 - 70% December 2015 – 90% William H. Maisel, MD, MPH – CRT 2015

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

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