the size of a device pose engineering problems, but hormonal influences and the activity levels of patients also need to be factored into the design of devices. Obtaining approval for use of a device in the pediatric population is also not an easy undertaking; ample evidence indicating that it has been properly designed for children and that the safety and efficacy are demonstrated rather than presumed must be made available.

Special considerations must be exercised when extrapolating safety and efficacy data in adults to children in the areas of drugs, biologics, and medical devices. The summaries of the presentations that follow explore such issues, including when and how safety and efficacy data can be used for children.

SPECIAL CONSIDERATIONS FOR EVALUATING MEDICAL DEVICES IN INFANTS AND CHILDREN

Presented by David W. Fugal, Jr., M.D., M.P.H.

Director, Center for Devices and Radiological Health, U.S. Food and Drug Administration

Nearly 8,000 manufacturers have medical devices registered with the U.S. Food and Drug Administration (FDA). Many of these are specifically designed for children. Examples include heart valves, fetal bladder stents, medical equipment for the neonate, and hydrocephalus shunts. There are also life-supporting and life-sustaining products such as ventilators, rate-responsive pacemakers, and hemodiaylsis machines. These devices often cannot just be devices adapted from adult use. Even something as simple as the change needed in the size of a catheter lumen changes the flow characteristics and may critically affect product performance. Children grow and implants such as heart valves and hip prostheses need to be designed to accommodate growth or be designed for replacement. Changes in the type and level of activity occur rapidly from infancy to adulthood; some devices need to be developed with consideration given to the hormonal and body size changes that rapidly occur at adolescence.

To gain approval for a device for children, there must be evidence that it is properly designed for children, as well as a demonstration of safety and effectiveness. In contrast to drugs, for which formulation changes and improved palatability might be sufficient to develop a pediatric formulation, developers of pediatric devices must be focused on the performance and controls needed to adapt a device for a pediatric patient. Recently, the FDA centers responsible for drugs and biologics reviewed their approved products to identify those with inadequate clinical information to support pediatric labeling and published a list calling for pediatric studies. Contemplating a similar task for devices is daunting. Even aside from the fact the nearly half of all newly marketed devices are exempt from premarket applications, 4,500 new devices are approved



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