Medical device regulation: what a practicing dermatologist should know.
The practicing dermatologist uses many medical devices during his or her day-to-day practice. The authors present a broad overview of how such medical devices are reviewed for safety and reasonable assurance of effectiveness, and evaluated for classification prior to marketing in the United States by the Food and Drug Administration. The specific example of dermal fillers as a class III medical device is discussed together with its regulatory ramifications. This article is written by staff currently employed at the Center for Devices and Radiological Health and should provide information useful to the practicing dermatologist.
Dang
Jiyoung M
JM
US Food and Drug Administration, Center for Devices and Radiological Health, Office of Device Evaluation, Rockville, Maryland 20850, USA.
Krause
David
D
Felten
Richard P
RP
Luke
Markham C
MC
Luke
Markham K
MK
D003880:Dermatology; D017277:Drug Approval; D004864:Equipment and Supplies; D006801:Humans; D012871:Skin Diseases / Q000628:therapy*; D014481:United States; D014486:United States Food and Drug Administration