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FDA Issues Final Guidance on Benefit-Risk Factors to Consider in Medical Device Product Availability, Compliance, and Enforcement Decisions

23 January 2017

Medical Device Alert

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.

FDA has indicated that it intends to use a consistent approach to benefit-risk analysis in considering compliance and enforcement actions and decisions on premarket applications.

Read further for details on benefit and risk factors.


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