Dear Reader:

To say that we, in ODE, are living in an era of change is a major understatement. We are being asked to provide objective performance measures by way of scorecarding, move towards becoming an e-office, look 5 and 10 years down the road for strategic planning, design and manage a user fee program with outcome goals that are different and more challenging than any we have seen before, and look at ourselves as a part of the TPLC universe rather than the center of the premarket universe. And, as if these challenges aren’t enough, we have the responsibility to do all of this with yet another new Director, and through it all not miss a beat when it comes to meeting our daily review quotas.

Based on past performance, I have no doubt that we will accomplish all this and more. Looking at the myriad of new technology evaluations, outreach programs, guidances, standards, and other initiatives documented in this report, I believe that what we have accomplished in the last twelve months is nothing short of astounding. I take it as a clear indication of what we will be capable of with additional resources and an effective plan to manage those resources.

I look forward to working with those of you within ODE, CDRH, and all of our many stakeholders to look at ways to communicate more effectively, improve out decision –making processes, and carry out our public health mission in a way that is fair, timely, and based upon the best available science.

Daniel G. Shultz, M.D.
Director, Office of Device Evaluation