FY 2003 OHIP Annual Report - Introduction

OHIP provides services that directly affect the lives of millions of Americans. As one of the Offices within the Center for Devices and Radiological Health (CDRH), Food and Drug Administration (FDA), we specialize in program-based communication, education, radiological health, mammography quality, and reduction of use error.

FY 2003 was noteworthy for OHIP in many program areas. These noteworthy accomplishments are discussed in detail throughout this report. Overall, OHIP’s work is guided by the CDRH mission and vision. Mission: to promote and protect the health of the public by ensuring the safety and effectiveness of medical devices and the safety of radiological products. Vision: “Ensuring the health of the public throughout the Total Product Life Cycle.”

During FY 2003, OHIP worked toward the CDRH mission, vision and strategic goals. These goals include the following:

• to apply the total product life cycle model across all CDRH activities;
• to serve as a magnet for excellence in attracting and retaining a diverse workforce who want to help us fulfill our public health mission;
• to manage knowledge in support of the total product life cycle model; and
• measure and communicate our public health impact.

Throughout this report, you will see that outreach and education are in all aspects of our work. This is evident whether we are producing teleconferences, training CDRH staff, working with patients/consumers/health professionals, assuring high quality mammography, conducting radiation safety surveys, answering device industry questions, or writing regulations. As we carry out our programs, we emphasize collaboration both within and outside CDRH. Coalition building, public participation, and information exchange allow us to obtain input from all relevant and concerned sources and to leverage and multiply our resources to protect the public health.

Because of the breadth of our role within CDRH, we serve a wide variety of customers. Our customers include:

• domestic and foreign manufacturers of medical devices and radiation-emitting electronic products;
• domestic and foreign government agencies engaged in public health and the regulation of medical devices;
• healthcare professionals and healthcare facilities, as well as the organizations that represent them;
• consumers and patients, including all women in the United States who receive mammograms; and,
• CDRH staff who benefit from training and professional development activities.

We think that each of our customers will find programs of interest in this report. We welcome your review and your comments on our efforts and our future directions.