In January we released to the public and began implementing our 2010 strategic plan. The plan, CDRH FY 2010 Strategic Priorities, identified four priority areas of activity that presented significant opportunities to improve our effectiveness in fulfilling our mission. In an effort to set both clear and aggressive timelines, the strategic plan included time-bound goals associated with each strategy we were planning to implement, and time-bound actions associated with the goals listed under each strategy.

We committed to achieve many of the goals in fiscal year (FY) 2010. For those goals that would take longer to accomplish, we identified the supporting actions we would take in FY 2010 to stay on track . In total, we committed to 123 actions, with 107 of those actions due in FY 2010. Recognizing that by setting aggressive timeliness many of the deadlines we set for ourselves were really stretch goals, we set as our performance target accomplishing at least 85 percent of the actions with due dates in the fiscal year. (See CDRH’s FDA-TRACK Management Dashboard.)

We are pleased to report that we met our FY 2010 performance target having successfully completed 86 percent, 92 of the 107 actions due in FY 2010. As of November 30, 2010 we have successfully completed 91percent, 99 of 109 actions due by the end of November. The following examples highlight some of our accomplishments:

• We completed and released for public comment two preliminary reports recommending concrete steps we could take to strengthen the 510(k) program and increase the predictability of our use of science in regulatory decision making by fostering medical device innovation, enhancing regulatory predictability, and improving patient safety.
• We launched the CDRH Transparency Website; a website which will eventually serve as a one-stop-shop for publicly released information about our decisions, as part of our efforts to increase transparency in our decision making.
• We implemented the CDRH Leadership Program and are finalizing the development of core competencies and recommended coursework for premarket reviewers and medical officers, as part of our effort to enhance CDRH’s ability to meet the Center’s mission critical needs and to maintain high-quality employees.
• We established and held a public meeting of the Council on Medical Device Innovation, comprised of representatives from FDA and other federal agencies, as part of our efforts to proactively facilitate medical device innovation to address unmet public health needs. We also worked, and continue to work, with industry and others to facilitate improvements in the design of devices that have been associated with safety problems across multiple manufacturers: (i) in February, we announced an Initiative to Reduce Unnecessary Radiation Exposure from Medical Imaging; ucm199904 and (ii) in April, we announced the Infusion Pump Improvement Initiative.

Before we issue our strategic plan for 2011, we want to highlight the significant amount of work accomplished by our dedicated staff in support of the FY 2010 Strategies Priorities. The tables below provide an account of the status of those goals and actions whose due dates have elapsed as of November 30, 2010. Following a scorecard approach, we used a checkmark to indicate actions and goals we accomplished; we labeled with “Started” actions that are ongoing; and used italics to indicate actions not covered by this progress report.

Strategy 4.1. Foster the Development of Medical Devices to Respond to Unmet Public Health Needs

Goal 4.1.1. By June 30, 2010, CDRH will identify the top five most important unmet public health needs.
By March 31, 2010, establish a Council on Unmet Public Health Needs (Council) composed of participants from federal agencies.
By June 30, 2010, the Council will hold one or more public workshops to identify the most important unmet public health needs and the barriers to the development of medical devices that can cure, significantly improve, or prevent these illnesses or injuries.
Goal 4.1.2. By September 30, 2010, CDRH will establish an internal capacity to facilitate the development of medical devices to address unmet public health needs.
By July 31, 2010, hire a medical device innovation coordinator.
By September 30, 2010, identify key agency staff who will devote at least part of their time to medical device innovation and establish roles and responsibilities.
Goal 4.1.3. By September 30, 2010, CDRH will identify the necessary steps to facilitate development of medical devices to respond to at least two of the top five most important unmet public health needs.
By September 30, 2010, based on information obtained from the public workshop(s) and through other means, the Council will identify the steps the federal government can realistically take to remove or minimize barriers to the development of devices respond to two or more of the top five most important unmet public health needs.
Goal 4.1.4. By September 30, 2010, CDRH will establish at least one mechanism to solicit innovative solutions to unmet public health needs from external constituencies.
By July 31, 2010, identify feasible, high return-on-investment options.
By September 30, 2010, implement one to two of the identified options across all devices or for specific types of devices.
Goal 4.1.5. By September 30, 2010, CDRH will identify and publicly announce steps we will take to facilitate improvements in the design of device types that have been associated with safety problems across multiple manufacturers.
By June 30, 2010, identify two or more device types that have been associated with safety problems across multiple manufacturers.
By September 30, 2010, identify and publicly announce steps CDRH will take to address problems with the identified device types through improvements in device design.

Strategy 4.2. Develop a Personalized Medicine Program

Goal 4.2.1. By December 31, 2010, CDRH will have in place the infrastructure and procedures for managing personalized medicine submissions across Centers.
By December 31, 2009, develop methods for identifying and tracking therapeutic/in vitro diagnostic (IVD) personalized medicine submissions within CDRH.
By June 30, 2010, develop draft formal mechanisms to address Personalized Medicine issues between CDRH, CBER, CDER, and OCP.
By December 31, 2010, develop methods for identifying and tracking therapeutic/non-IVD diagnostics personalized medicine submissions within CDRH.

    

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