CDRH 2010 Strategic Priorities Jeffrey Shuren, M.D., J.D. Director, Center for Devices and Radiological Health February 23, 2010

CDRH 2010 Strategic Priorities Priority 1. Fully implement a total product life cycle approach Priority 2. Enhance communication and transparency Priority 3. Strengthen our workforce and workplace Priority 4. Proactively facilitate innovation and address unmet public health needs

Priority 1. Fully implement a total product life cycle approach We will take steps to enhance and integrate our premarket, postmarket, and compliance information and functions

Priority 1. Fully implement a total product life cycle approach Improve the quality and consistency of our regulatory decision making by strengthening our premarket review programs Assess the 510(k) process Internal 510(k) Working Group recommendations Will include feedback from public docket and public meeting Institute of Medicine’s report on the 510(k) program Improve the quality of clinical data submitted in support of Premarket Approval Applications

Priority 1. Fully implement a total product life cycle approach Enhance our systems and processes for collecting, analyzing, and sharing information to support the day-to-day needs of employees throughout the Center Increase our ability to capture and more effectively use meaningful data on marketed devices Unique Device Identification (UDI) system iReview – electronic premarket review system Traction – social media tool Begin to develop integrated systems and processes for knowledge management Signal escalation Device registries Hire a senior-level medical officer to coordinate pediatric activities across CDRH

Priority 1. Fully implement a total product life cycle approach Prepare the Center to face the demands of the future Establish mechanisms to incorporate new scientific information into our regulatory decision making in a transparent and predictable manner. Internal task force on the use of science in regulatory decision-making Will include feedback from public docket and public meeting

Priority 1. Fully implement a total product life cycle approach Strengthen our efforts to address changes in the global-market landscape Improve the coordination of international activities across CDRH. Associate Director for International Affairs Develop mechanisms to exchange and make better use of medical device information with trusted foreign authorities. GMP inspections Finalize and begin to implement the Compliance Strategic Plan that is currently in development

Priority 1. Fully implement a total product life cycle approach Re-examine our organizational structure Assess possible organizational changes for the Center that would effectuate integration. Changes within the Office of the Center Director: Deputy Center Director for Science Deputy Center Director for Policy Improve guidance and regulation development in the Center Clarify the roles, responsibilities, and processes for drafting and clearing guidance documents and regulations

Priority 2. Enhance communication and transparency We will provide meaningful and timely information about the products we regulate and the decisions we make

Priority 2. Enhance communication and transparency Develop a strategic approach to public communication by building on the foundation of the Center’s Risk Communication Processes Associate Director for External Relations Implement mechanisms that will enable our external constituencies to routinely engage with us in a two-way dialogue Periodic town hall meetings in different parts of the country (3 meetings in CY 2010)

Priority 2. Enhance communication and transparency Increase transparency in our decision making, consistent with the efforts of the Agency’s Transparency Task Force CDRH Transparency Website A one-stop-shop for publicly released information about our decisions

Priority 3. Strengthen our workforce and workplace Maintaining a skilled staff and a productive work environment will enable CDRH to address the many challenges presented by the range of products we oversee

Priority 3. Strengthen our workforce and workplace Enhance our ability to recruit, develop, and retain high-quality employees Center succession program Lead reviewer and medical officer core competencies training Strengthen employee training Leverage the knowledge and experience of external experts External Expertise & Partnerships Program (EEP) Establish a Network of Experts

Priority 4. Proactively facilitate innovation and address unmet public health needs We will take a more proactive role in facilitating medical device innovation

Priority 4. Proactively facilitate innovation and address unmet public health needs Work with our federal government partners to identify the most important unmet public health needs and minimize barriers to the development or redesign of devices to alleviate or prevent these illnesses Facilitate improvements in the design of device types that have been associated with safety problems across multiple manufacturers

Priority 4. Proactively facilitate innovation and address unmet public health needs To support medical device innovation efforts we will: Hire a medical device innovation coordinator Identify CDRH staff that will devote at least part of their time to fostering medical device innovation Lay the groundwork for overseeing innovative diagnostics and therapeutics products Develop the infrastructure and processes for managing personalized medicine submissions across Centers

CDRH 2010 Strategic Priorities FDA.gov (Strategic Planning Website) http://www.fda.gov/AboutFDA/CentersOffices/CD RH/CDRHVisionandMission/ucm197647.htm