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# Guide on Benefit-Risk Factors When Making Enforcement Decisions
- URL: https://www.fdaweb.com/guide-on-benefit-risk-factors-when-making-enforcement-decisions/
- Published: 2017-01-03T12:00:00.000Z
- Updated: 2026-09-14T21:57:41.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5137623

FDA has issued a [guidance](http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM506679.pdf?ref=fdaweb.com) on “Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions.” The document describes the general framework for medical device decision making in the product availability, compliance, and enforcement arenas. “Product availability and other medical device compliance and enforcement decisions are generally fact-specific,” the guidance says. “However, FDA believes that explaining how we consider the factors listed in this guidance document 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.”