FY 2005 OIVD Annual Report Preface
Letter from the Director
The Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) is now 3 years old. We remain firmly committed to the objective put on the table when our organization was first launched: to actualize total product life cycle regulation for In Vitro Diagnostic Devices (IVDs).
During 2005 we have made significant strides in meeting that goal. We have completed processes to integrate all three critical regulatory functions for IVDs - premarket review, compliance oversight, and postmarket surveillance - into a single functional unit.
While we have worked studiously to ensure our activities are congruent with work throughout our center, our work differs in several ways. It is now driven from a common technical base which allows both external and internal stakeholders one stop shopping for IVD information. In addition, we have begun to utilize the geographic and organizational features of our office to create powerful and growing connections between our disparate regulatory programs.
This integration of diverse work has been accomplished while meeting the challenges of our routine work and includes: 11 premarket approval application (PMA) reviews, 520 premarket notification 510(k) reviews, 7 Class I recalls, 3 warning letters and 9605 MDR reviews; implementing MDUFMA hiring, training and goals; and identifying and training staff to perform new regulatory functions in a multifunctioning, matrix driven organization.
While we believe we have made a significant start toward creating a unique new office with its own identity, culture, and work processes, our eye is on the future. The IVD industry is brimming with new ideas, technologies, and biological insights that are likely to create a diagnostic revolution in medicine in the next 5 to 10 years. In particular, the drive toward personalized medicine and the use of diagnostics to shorten the critical path to introduction of new drugs, the interest in diagnostic markers for bioterrorism threat preparedness and for dealing with emerging infectious disease such as avian flu, and the development of portable systems to increase access to rapid testing, are likely to drastically impact patient health and safety.
OIVD is up for the challenge of becoming an engaged and proactive member of this diagnostic revolution. It is our hope that our role at the table will be one of facilitator and partner rather than obstacle. We are committed to the important mission of promoting and maintaining availability of safe and effective diagnostics for use in the medical marketplace.
Steven Gutman, M.D., M.B.A.
Office of In Vitro Diagnostic Device
Evaluation and Safety