FDA > CDRH > Strategic Plan > CDRH 2006 Priorities

CDRH 2006 Priorities

I’d like to share with you some important information about the recent senior staff planning meeting, and to enlist your support for the Center’s FY 06 priorities.

On August 23-24, our senior staff met to review the Center’s major programs, assess next year’s budget, and identify priorities for FY 06. Following the presentations and discussions, there was clear consensus among the managers that the Center needs to enhance its focus on postmarket information and stakeholder communication. These discussions also highlighted the need to optimize the balance of and interaction among key Center programs.

Here’s a complete list of FY 06 priorities:

1. Increase our ability to identify, analyze and act on postmarket information in order to enhance the safety and effectiveness of medical devices and radiological products throughout their product life cycles.
    
2. Improve our communication of risk/benefit information to all of our stakeholders.
    
3. Continue to implement and assess MDUFMA 1 and prepare for MDUFMA 2.
    
4. Advance the "critical path" for medical and radiological products through internal and external collaboration in research, guidance and standards development, and innovative regulatory models.
    
5. Invest resources strategically to support the priorities of HHS, FDA, and CDRH.

How do these general priorities translate into programmatic action?

• A report on the Center’s postmarket programs is currently being drafted, and its recommendations will serve as the basis for making improvements across the Center. For example, we want to make sure MDR reviews and health hazard analyses that contribute to the recall process include input from the device review group, as well as laboratory scientists knowledgeable in that product area. Similarly, we need to make sure MDR and compliance data are readily available to device reviewers so that all postmarket information is considered as they are making safety and effectiveness review decisions.
   
• We reviewed the Center’s current outreach efforts and discovered that although we are making a strong effort to get the Agency’s word out, most of our outreach has been focused on industry. Although it is often more difficult to assess and address the information needs of health professionals and consumers, it is important that we take steps to enhance our outreach to these groups, possibly with help of professional societies. We’re planning to focus more clearly on risk communication, with a new web direction and increased web development.
   
• We reviewed the Center’s remarkable MDUFMA 1 performance record in FY 05. I strongly believe MDUFMA 1 has strengthened the review process with updated review standards, guidance and quality assessments. Along with reductions in review time, MDUFMA 1 has helped us build a Center-wide culture that emphasizes coordination and accountability. Continued implementation of MDUFMA 1 and preparing for MDUFMA 2 will be a high priority for FY 06.
   
• For FY 06 we will continue to advance the “critical path” initiative for medical and radiological products. We plan to increase our internal and external collaborations with academic, business, professional, and regulatory groups to leverage the development of analytic models that can help to get safe and effective products to market more quickly, and ensure continued safety and effectiveness for products already on the market.
   
• The availability of robust, inter-connected systems that allow for readily available information about the products we regulate improves productivity and public health accountability. Accordingly, we made plans to take a long-term systems approach to our information technology development in FY 06. We agreed that staff subject matter experts need to work closely with IT staff to ensure the systems we plan and put in place address and improve the way we do our core business. We also will to continue to provide both IT systems support and other “knowledge management” procedures to make sure we share information effectively throughout the product life cycle.

During the meeting we also assessed what our overall FY 06 budget is likely to be, and began the discussions that will help us allocate CDRH funds next fiscal year. The senior staff agreed to make review of time reporting categories a high priority in order to have the best information available to make management decisions as we go forward.

I want to close by thanking you for helping us achieve the Center’s remarkable performance in FY 05. I know that this took a lot of extra effort, and I appreciate it. Building on the strong foundation of MDUFMA 1 will help us in achieving the FY 06 priorities.

Please feel free to talk to your Office Director or Deputy Office Director about the initiatives I’ve discussed here. I’ll keep you updated as plans for next year proceed.

Each of you will play a critical part in helping us achieve our priorities. Thank you for your continued support.

Dan Schultz, M.D.

Updated September 2, 2005