FDA GUIDANCE ON ASSESSMENT OF PEDIATRIC MEDICAL DEVICES

As required by the Medical Device User Fee and Modernization Act of 2002 (P.L. 107–250), FDA recently provided guidance on the premarket assessment of pediatric medical devices. The guidance includes a general discussion of developmental considerations and lists a number of factors that should be considered in designing devices or planning clinical studies of devices (FDA, 2004p). The listed factors, which are not mutually exclusive or exhaustive, are
• height and weight;
• growth and development;
• disease or condition;
• hormonal influences;
• anatomical and physiological differences from the adult population;
• activity and maturity level; and
• immune status.
In a further discussion of “unique host characteristics” of pediatric patients, the guidance offers some illustrations of how these characteristics might figure in the assessment of a medical device(cheap medical equipment). For example, in recommending that assessments consider stage of puberty and other developmental milestones, the guidance suggests that clinicians should consider breast bud development in the placement of certain medical devices in infant or young girls (e.g., placement of chest tube in a tiny infant to relieve air or fluid that has collected in the chest, but outside the lungs).

The guidance also summarized the circumstances when clinical data for pediatric populations are appropriate. These circumstances are when • supporting information from sources, such as preclinical bench or animal testing, literature, or adult clinical trials, are inadequate to establish safety and effectiveness for the pediatric indication;
• adult data are inadequate to predict pediatric risks and adverse events;
• pediatric data are needed for validation of design modifications; or
• pediatric data are needed to develop an age-appropriate treatment regimen.
Specific testing requirements will vary depending on the device. FDA, however, stated that its expectations for such tests generally involve the same basic questions and procedures for both adult and pediatric populations.

An article by FDA staff includes additional discussion of pediatric factors as they relate to neurological devices (Pena et al., 2004). With respect to surgical risks, for example, the authors cite concerns about blood loss for patients with small volumes of blood, possible need for sedation for children who cannot control movement during procedures, and repeat surgeries associated with device replacement or growth-associated migration of a device. They note that of 19 high-risk medical devices involving the central and peripheral nervous system that FDA approved between 1994 and 2003,

8 included indications for use in children as well as adults.
In addition to the guidance on premarket assessment, the agency issued guidance on procedures to ensure that advisory panels that review documents such as applications for premarket approval of medical devices appropriately(cheap ultrasound machine) include or consult with pediatric experts. This guidance, which responds to another provision in the Medical Device User Fee and Modernization Act, provides for pediatric expertise to be available (through consultation or inclusion in panel deliberations) in a range of situations. These include when

• there are labeled indications for use that include a pediatric subpopulation or there is a reasonable likelihood that the device would be used in a pediatric subpopulation for the labeled indication;
• there are data in the study that include a pediatric subpopulation;
• there is a reasonable likelihood that the data from the study in the adult population may be used by the applicant to subsequently support a pediatric indication;
• there is a need for advisory panel input on a study design and/or
protocol for use of the device in the pediatric population; or
• there is a reasonable likelihood that the advisory panel may discuss the potential use of the device in the pediatric population.
The next section of this chapter considers how children’s special needs and characteristics may be taken into account in the design and use of medical devices. The descriptive categorizations reflect the committee’s experience and perspectives, reviews of the literature, and information provided during public meetings and other discussions with experts.