Regulation of Medical Devices for Dermatology.

Medical devices became subject to the current framework of regulation and premarket review by the Food and Drug Administration (FDA) in 1976. Devices are distinguished from drugs by the means in which they achieve their primary intended purposes. All medical devices, regardless of risk, share certain regulatory requirements to assure quality, safety, and transparency. Moderate- to high-risk devices must additionally be cleared or approved by FDA before being introduced into interstate commerce. Dermatologic devices regulated by FDA range from high-power energy-based devices to wound dressings, and from complex electronic devices to topically applied barrier creams.