Postmarket Modifications of High-risk Plastic Surgery Devices.

Abstract

In the United States, high-risk medical devices must be cleared through the premarket approval (PMA) pathway, which requires clinical evidence ensuring safety and efficacy. Approved devices can be modified and reintroduced to market without additional study through the PMA supplemental review track. This study characterizes the changes of high-risk plastic surgery devices once they undergo initial clearance. A retrospective, cross-sectional analysis of the Food and Drug Administration (FDA) PMA