Business · 27/12/2016

FDA Releases Guidance on Benefit-Risk Analysis for Medical Devices

The Food and Drug Administration (FDA) has released a guidance document titled 'Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions' to provide clarity on how the agency assesses the benefits and risks of medical devices in its decision-making process. This guidance aims to enhance consistency and transparency in FDA's compliance and enforcement efforts, ultimately prioritizing patient safety and quality of medical devices.