Dermatologic Device Clearance Within the Food and Drug Administration's 510(k) Pathway.

Abstract

Device innovation in dermatology is increasing. Medical devices identified as "substantially equivalent" to predicate ones by the United States Food and Drug Administration (FDA) may be exempt from premarket approval through the 510(k) pathway. The 510(k) pathway has been criticized for having less stringent clinical data requirements, and implications of dermatologic device clearance via this pathway are incompletely described. The objective of this study is to characterize dermatologic device