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U.S. Department of Health and Human Services

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FY 2001 ODE Annual Report Preface

Dear Reader:

Welcome to our FY 2001 Annual Report. It's a very positive report in many respects. The Office of Device Evaluation approved 53 PMAs last year. This is ten more than we approved in fiscal year 2000 and, in fact, is the largest number approved in any year over the last decade.

Our submission review times are respectable. The PMA turnaround time, based on decision cohorts, is somewhat longer than the previous year's results because we cleared the decks of older PMAs that were on our to-do list. The turnaround times for 510(k)s were actually modestly shorter than those for fiscal year 2000.

Part 1 of the report - ADVANCES IN PATIENT CARE - consists of a selected group of high profile and clinically significant devices approved or cleared in this fiscal year. Each of the six divisions is well represented. These representative medical devices include products used for improved vision, for assisting patients with congestive heart failure, for ease of diagnosis of gastrointestinal disorders and for improved laboratory testing for hepatitis. We hope to add to this list over the coming years with additional innovative and clinically valuable devices.

The remaining parts of the report present key information regarding the numbers and the types of submissions, the review times for each and the comparison with previous years' results. We also list guidances produced and presentations made during the past fiscal year as well as giving a complete roster of ODE staff responsible for the accomplishments during the fiscal year.

I am indebted to the superb ODE staff professionals and support staff. They have done all the hard work of carefully assessing the many submissions that we receive. I would like to express my appreciation to the other CDRH Offices that provided support and special expertise in the evaluation of premarketing submissions. I also acknowledge the medical device industry that continues to develop innovative products for patient care. Last, but certainly not least, we dedicate this annual report to the patients that will ultimately benefit from all of these devices. Hopefully we serve your needs efficiently and effectively. We want to do the right thing and we want to do it with dispatch.

The ODE managers and I hope you find this report useful, and that you enjoy reading it. Please send any comments to us at odereport@cdrh.fda.gov so that we can improve our annual reports in the years ahead.

Now, enjoy the tables, the graphics and the other information found on the following pages.

Signature of Bernard E. Statland, M.D., Ph.D.Bernard E. Statland, M.D., Ph.D.
Director, Office of Device Evaluation

Signatures of Philip Philips, Daniel Schultz, Carl DeMarco, Nancy Pluhowski, Nancy Brogdon and Steven Gutman
signatures of Ralph Rosenthal, Tim Ulatowski, Celia Witten, Bram Zuckerman, Kathryn Appler and Robert Gatling