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U.S. Department of Health and Human Services

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FY 2007 and 2006 ODE Annual Report Preface

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Dear Reader:

When we review our accomplishments, major challenges, and goals for 2006 and 2007, we are proud of what we have accomplished with our collective endeavors.

The passage of the Food and Drug Administration Revitalization Act of 2007 (FDARA) reauthorized FDA to collect user fees and contained other provisions for the medical device review program. FDARA also presents us with a more challenging set of performance goals. In order to meet these challenging new goals we have done several things. We developed an interactive review guidance document; modified our Center Tracking System (CTS) to enable staff to manage the new performance goals and the interactive review process; we are revising the original MDUFMA I PMA and 510(k) guidance documents to reflect the changes in the MDUFMA II legislation; we established new review timelines for original PMAs, PMA supplements, and 510(k)s to reflect the changes in the MDUFMA II legislation; and we have been developing essential training for all staff members on the new MDUFMA II performance goals, the interactive review process, and the new CTS features.

MDUFMA performance goals, Post-market Transformation, and rapidly advancing medical device technology present new challenges that necessitate further changes to the ODE program. I have the utmost confidence in our ODE staff for their continued support and commitment to promote and protect the public health. With all of us working together, we will be successful in meeting these challenges.

In closing, I want to acknowledge the support from our Center Director and the support from the other Offices in CDRH. Collaboration and communication are essential to the CDRH mission to promote and protect public health.

Donna-Bea Tillman signature

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