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Cosmetic Medical Devices and Their FDA Regulation

Cosmetic Medical Devices and Their FDA Regulation 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, http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png JAMA Dermatology American Medical Association

Cosmetic Medical Devices and Their FDA Regulation

JAMA Dermatology , Volume 142 (2) – Feb 1, 2006

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References (6)

Publisher
American Medical Association
Copyright
Copyright 2006 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.
ISSN
2168-6068
eISSN
2168-6084
DOI
10.1001/archderm.142.2.225
pmid
16490851
Publisher site
See Article on Publisher Site

Abstract

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,

Journal

JAMA DermatologyAmerican Medical Association

Published: Feb 1, 2006

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