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

2. 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

3. 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

4. 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

5. 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

6. 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

7. 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

8. 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

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

10. 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)

11. 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

12. 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

13. 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

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

15. 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

16. 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

17. CDRH 2010 Strategic Priorities
FDA.gov (Strategic Planning Website)
RH/CDRHVisionandMission/ucm htm