Benefiting From FDA's Medical Device Risk-Benefit Guidance

Law360, New York (July 25, 2016, 4:30 PM EDT) -- Daniel S. Wittenberg

Timothy P. Scalo On June 16, 2016, the U.S. Food and Drug Administration published draft guidance titled Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance and Enforcement Decisions.[1] The nonbinding draft guidance provides clarity to FDA staff and the medical device industry by setting out the benefit and risk factors the FDA may consider for decisions concerning product availability, compliance and enforcement. Although these decisions are generally fact specific, the FDA hopes that describing the factors will lead to a more consistent and transparent approach that focuses on maximizing patient benefits, reducing patient risks and...

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