Medical Device Recalls and the FDA Approval Process

February 14, 2011. Unlike prescription drugs, medical devices are reviewed by the US Food and Drug Administration (FDA) using 2 alternative regulatory standards: (1) premarket approval (PMA), which requires clinical testing and inspections; or (2) the 510(k) process, which requires that the device be similar to a device already marketed (predicate device). The second standard is intended for devices that the FDA deems to involve low or moderate risk.

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Teenagers and Cosmetic Surgery: Focus on Breast Augmentation and Liposuction

Journal of Adolescent Health, October 2008. Two of the most popular and controversial cosmetic procedures for adolescents are liposuction and breast implants. It this review article, the procedures are discussed. In addition, the physiological and psychological reasons to delay these procedures, including concerns about body dysmorphic disorder and research findings regarding changes in teenagers’ body image as they mature, are described.

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