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Guidance on Benefit-Risk Considerations for Device Enforcement

06/16/2016

Federal Register Notice: FDA is making available a draft guidance entitled Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions. It is intended to provide clarity for FDA staff and industry on the benefit and risk factors the agency may consider in prioritizing resources for compliance and enforcement efforts to maximize medical device quality and patient safety. To download this guidance, click here. To view this notice, click here.

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