Every day, the Office of Health and Industry Programs (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), U.S. Food and Drug Administration (FDA), we specialize in program-based communication, education, radiological health, mammography quality, and reduction of use error.

When thinking of OHIP’s role in CDRH, Outreach and Education always come to mind. Outreach and education are in all aspects of our work – whether we are producing teleconferences, training CDRH staff, working with patients and consumers, 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 appropriate 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, OHIP serves a wide variety of customers, including:

• domestic and foreign manufacturers of medical devices and radiation-emitting electronic products;
• other 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 believe that each of our customers will find programs of interest in our FY2000 Annual Report. We also believe that these programs and our accomplishments reflect changes and improvements that have been implemented as a result of OHIP strategic planning. In 1997, OHIP began implementation of an ambitious five-year strategic plan. As a first step, we received specific feedback from our customers in all of our program areas. While our customers were generally satisfied with our services, we also received many suggestions and comments for changes and improvements. After listening to our customers, OHIP developed four specific goals:

• to use collaboration and cooperation whenever appropriate to improve the quality and effectiveness of CDRH programs, to enhance the satisfaction of our customers, and to use CDRH resources most effectively;
• to consistently produce high quality and timely products and services;
• to identify, develop, implement and evaluate innovative and cost-effective approaches to accomplish vital new OHIP, CDRH and FDA initiatives; and
• to maximize OHIP’s use and development of human and fiscal resources.

OHIP is now in the fourth year of our strategic planning process. As reflected in our Annual Report, OHIP’s four goals are now tightly integrated into our programs and daily operations. During the coming year, we will continue to update and refine our strategic plan. We will also be concentrating our efforts on participation in the CDRH strategic plan. As the plan is implemented, it will provide broad principles and goals that CDRH will commit itself to over the next several years.

Finally, CDRH has proposed four strategic goals to fulfill the vision:

• 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
• to develop meaningful metrics to assess our continuing impact on public health and our communication with stakeholders.

OHIP is working with all of CDRH in the first stages of implementing these strategic goals. We are co-leading the magnet for excellence goal group and we lead outreach efforts inherent in all four goal groups. Together with you, our stakeholders, we are preparing a roadmap for the future of OHIP and for CDRH. For more detailed information on the CDRH strategic plan, visit the CDRH website at http://www.fda.gov/cdrh/ocd/strategic.html.

We welcome your review of OHIP’s FY2000 Annual Report and your comments on our programs and future directions.