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Medical Devices and Adolescents Points to Consider ONLINE FIRST

Joy H. Samuels-Reid, MD1; Judith U. Cope, MD, MPH2
[+] Author Affiliations
1Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices, Office of Device Evaluation, Center for Devices and Radiological Health, US Food and Drug Administration, Silver Spring, Maryland
2Office of Pediatric Therapeutics, Office of Special Medical Programs, Office of the Commissioner, US Food and Drug Administration, Silver Spring, Maryland
JAMA Pediatr. Published online September 12, 2016. doi:10.1001/jamapediatrics.2016.1351
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This Viewpoint discusses the special issues that should be considered in any treatment plan for adolescents involving medical devices.

Use of medical devices in adolescents presents many challenges. The Center for Devices and Radiological Health of the US Food and Drug Administration (FDA) defines the pediatric population as birth through age 21 years, with the adolescent age group defined as ages 12 through 21 years.1 Following the Food and Drug Administration Amendments Act of 2007, the FDA implemented a requirement that medical device manufacturers provide readily available information in certain premarket applications on pediatric patients who have the disease or condition that the device is intended to treat, diagnose, or cure, even if the device is intended for adult use.2 It is imperative to ensure appropriate focus on adolescents. The adolescent population is not monolithic. It has unique subgroups spanning different age groups with various stages of development, and it includes gender-specific variations—all important factors for manufacturers, investigators, and clinicians to consider. In many cases adolescents are treated as young adults, and the fact that they are still part of the pediatric population is often lost. There are special issues that should be considered in any treatment plan for adolescents that involves medical devices.

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