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Cosmetic Medical Devices and Their FDA Regulation
Arch Dermatol. 2006;142:225-228.
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Clinical dermatology practice has expanded to include the use of many procedures and devices for cosmetic purposes. This is a consequence of not only the rising interest in aesthetic medicine but also the economic pressures on the practitioner participating in managed care plans, as well as increasing regulation and requirements of office practice. However, the increased reliance on new cosmetic procedures and devices has resulted in confusion over their real benefits and risks. This confusion has arisen, in part, as a result of aggressive marketing by manufacturers. For example, entering the cacophonous technical exhibits hall at the American Academy of Dermatology meeting is an experience similar to walking in the Central Bazaar in Istanbul, where myriad merchants are plying their wares, each exhorting the superiority of his product over that of his neighbor.
Many practitioners greet these innovative devices with unbridled enthusiasm, which tempers over time as the disadvantages and . . . [Full Text of this Article] MEDICAL DEVICE AMENDMENTS OF 1976
Device Classification Premarket Approval MEDICAL DEVICE APPROVAL VS DRUG APPROVAL
GUIDELINES FOR PRESCRIBING AND USING MEDICAL DEVICES
CONCLUSIONS
AUTHOR INFORMATION
Amy E. Newburger, MD
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