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U.S. Department of Health and Human Services

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FY 2004 ODE Annual Report Preface


Dear Reader:

When we look back on our accomplishments for 2004, chief among them will be implementation of new processes to enable us to meet our MDUFMA goals. In keeping with the CDRH vision of Total Product Lifecycle, this involved a Center-wide effort to develop milestones for the premarket review process. By creating a culture of shared commitment to these milestones, we will improve the timeliness of the premarket review pricess, and bring safe and effective products to market more quickly than ever. We have also used our MDUFMA resources to make much- needed improvements to several of our key IT systems, which has also improved our ability to manage our workload.

This year we have also strengthened our commitment to improving the quality of the science that underlies the premarket review program. The resources that MDUFMA provides have enabled us to continue to bring in many talented professionals, both as new hires and through the ever-expanding Medical Device Fellowship Program. MDUFMA has also allowed us to provide our staff with opportunites to refine their technical skills through attendance at training and scientific meetings. Through collaborations with other parts of CDRH, we have brought a new emphasis to guidance development and the use of voluntary standards.

This past year has seen much change for ODE. However, one thing has not changed, and that is the commitment that each and every one of us brings to our mission of promoting and protecting the public health. We look forward to working with all of our stakeholders in the coming years to ensure that we continue to be prepared to take on this important challenge.

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

Signatures of Aron Yustein, Carl Demarco, Nancy Pluhowski, Nancy Brogdon, Chiu Lin, David Whipple, Celia Whitten, Bram Zuckerman, Kathryn Appler, and Robert Gatling.