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U.S. Department of Health and Human Services

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FY 2005 ODE Annual Report Preface

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Dear Reader:

Henry David Thoreau instructed us that 'Our life is frittered away by detail... Simplify, simplify.' We have taken his words to heart in developing this year's ODE Annual Report. There are three reasons for this change: 1) MDUFMA has caused us to reassess how we think about our premarket review performance, and we wanted to present a more balanced view of our accomplishments; 2) It was time to recognize that the bold experiment that created OIVD had become the new reality, and thus it was time to start presenting ODE-only data. The historical data that we had was combined ODE/OIVD; and 3) We have discovered limitations in the computerized reporting system that we had historically used to generate these tables. In addition, we have provided a link (http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/ Overview/MedicalDeviceUserFeeandModernizationActMDUFMA/default.htm) to the performance data we have tracked, reported, and updated under MDUFMA. We think those measures are significant because we negotiated those goals with industry as the way to get safe and effective products to market most effectively; therefore, these are the goals to which we are managing. That being said, if there are performance statistics that we have not reported that are important to you, we encourage you to let us know by sending your comments to odereports@fda.hhs.gov. We will consider your comments in developing next year's ODE Annual Report.

In the meantime, I am excited to share with you a summary of the highlights of our accomplishments for FY 05. Yes, we are meeting, and in some cases exceeding, nearly all of the MDUFMA performance goals. But after reading this report, I hope that you will see that the impact of what we (and the Industry we regulate) have accomplished goes beyond improving the timeliness of the review process. Each and every day ODE staff are fulfilling FDA's public health mandate in a thousand different ways. Whether it be emergency preparedness for pandemic flu, developing better clinical trials for the next generation drug-eluting stent, or following up on pediatric patients with cochlear implants, ODE staff are playing a critical role. This annual report provides the highlights of what they have achieved in FY 05. I am proud to be part of their team, and I look forward to what we will achieve together in the following years.

Donna-Bea Tillman signature

Donna-Bea Tillman,
Ph.D. Director
Office of Device Evaluation