federal_register: 2016-31145

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2016-31145 Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions; Guidance for Industry and Food and Drug Administration Staff; Availability Notice The Food and Drug Administration (FDA or Agency) is announcing the availability of the guidance entitled "Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions." This guidance is intended to provide clarity for FDA staff and industry regarding the benefit and risk factors FDA may consider in prioritizing resources for compliance and enforcement efforts to maximize medical device quality and patient safety. Although product availability and other medical device compliance and enforcement decisions are generally fact-specific, FDA believes that explaining how we consider the factors listed in the guidance will improve the consistency and transparency of these kinds of decisions. A common understanding of how FDA considers benefit and risk may better align industry's and FDA's focus on actions that maximize benefit to patients, improve medical device quality, and reduce risk to patients. This guidance is in effect at this time. 2016-12-27 2016 12 https://www.federalregister.gov/documents/2016/12/27/2016-31145/factors-to-consider-regarding-benefit-risk-in-medical-device-product-availability-compliance-and https://www.govinfo.gov/content/pkg/FR-2016-12-27/pdf/2016-31145.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA or Agency) is announcing the availability of the guidance entitled "Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions." This guidance is...

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