Medical device regulation: what a practicing dermatologist should know

Abstract

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.

Demystifying the U.S. Food and Drug Administration

“…8 The Center for Devices and Radiological Health has placed devices into several classifications that require different regulatory pathways. 9 The inventor must first determine whether the product is considered a device. According to the Federal Food, Drug, and Cosmetic Act [21 U.S.C.…”