Dear Reader:

Fiscal Year 2003 was an exciting year for ODE. One might assume that with the creation of the new Office of In Vitro Diagnostic Device Evaluation and Safety, that things would have gotten simpler and easier for those of left behind in ODE. That assumption would be very wrong. You will see many references specific to OIVD in this report including a wonderful introduction by my colleague and friend Dr. Gutman. You will also see that many of our activities and reports remain closely intertwined.

This was the year when MDUFMA became a reality and many individuals were asked to participate in implementation of all its many facets. This was a year, when, for the first time in almost a decade, we experienced significant growth in our most precious resource adding more than 70 professionals from a broad range of scientific disciplines including engineers, scientists and physicians. Additional expertise was added through expanded use of contracts, interns and other innovative methods of bringing the right knowledge to the right problem at the right time.

This was a year when CDRH reaffirmed its commitment to training and professional development for our new employees as well as those of us “seasoned veterans.” Participation of approximately 95% of ODE staff in such activities demonstrates our ongoing determination to enhance the knowledge and skills needed to evaluate the cutting edge technology of today and tomorrow.

Speaking of innovative technology, this was a year that saw the introduction of the first drug-eluting stent, the first stair-climbing wheelchair, the first integrated glucose monitor and pump, and many other technological wonders that will help people lead longer and better lives. We recognize that there many more such products in the pipeline, and that the challenges of accomplishing our mission to evaluate their safety and effectiveness in a thorough and efficient manner will only increase. ODE, working with our colleagues throughout the Center, FDA, and our many sources of external expertise, will be ready to meet those challenges.

Dear Reader:
Welcome to the Office of In Vitro Diagnostic Device Evaluation and Safety’s FY 2003 Annual Report. We at OIVD live in times of extensive change in our regulatory program. Following the central tenant in the CDRH strategic plan to regulate using the Total Product Life Cycle (TPLC) we have combined three key regulatory programs for IVDs (premarket review, compliance, and postmarket safety monitoring) into a single geographic unit. This allows all IVD activity to spring from a common consolidated technical and regulatory base.
During the past year we have created a website to serve the needs of the IVD community. We have standardized IVD review processes and began posting our reviews on this web page. This allows for improved quality control and transparency in our premarket work.

Finally, we have taken important steps to develop a more coordinated patient safety program that leads to rapid identification and resolution of product defects and problems. This program consists of several components: (1) review of MDR reports by scientific reviewers involved in the review of the products being reported, (2) the LabSun pilot (an expansion of the successful MedSun program but focused on clinical laboratories), and (3) active listening and follow-up of issues from all sources (listservs, professional meetings, trade complaints, the internet, and professional contacts) that warrant FDA evaluation. Collectively, these efforts have led to the identification and resolution of a number of device problems of public health significance.

OIVD management and staff look forward to working with all our stakeholders to develop ways to improve our performance in protecting and promoting public health in a timely, fair, and transparent manner clearly grounded in good science.

Steve Gutman, M.D.
Director, Office of In Vitro Diagnostic Device Evaluation
and Safety