On December 27, 2016, the U.S. Food and Drug Administration (FDA) issued a final guidance document entitled "Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions." The guidance provides insight into the factors FDA considers when prioritizing resources for compliance and enforcement efforts and when undertaking compliance and enforcement actions. It is intended to harmonize the agency's approach to weighing benefits and risks for compliance and enforcement actions with the benefit-risk framework for assessing marketing and investigational device exemption applications.