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EDITORIAL LINICAL DERMATOLOGY PRACTICE HAS EX- the data supporting the risks and benefits of a medical panded to include the use of many pro- device, as well as the limitations of the evaluation of these cedures and devices for cosmetic pur- devices because only then can he or she use the device poses. This is a consequence of not only in a safe and effective manner. the rising interest in aesthetic medicine but also the economic pressures on the practitioner par- MEDICAL DEVICE AMENDMENTS OF 1976 ticipating in managed care plans, as well as increasing regulation and requirements of office practice. How- The term medical devices refers to a vast array of imple- ever, the increased reliance on new cosmetic proce- ments used in the practice of medicine to enhance the dures and devices has resulted in confusion over their health of the patient. A device is defined, in pertinent part, real benefits and risks. This confusion has arisen, in part, as “an instrument, apparatus, implement, machine, con- as a result of aggressive marketing by manufacturers. For trivance, implant, in vitro reagent, or other similar or re- example, entering the cacophonous technical exhibits hall lated article, including any component,
JAMA Dermatology – American Medical Association
Published: Feb 1, 2006
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