• News

    FDA to Hold Workshop on Defining Outcome Metrics for Orthopaedic Devices

    Date: October 30, 2012

    FDA internal experts will partner with academic and industry stakeholders to discuss challenges and approaches in defining minimum clinically important difference (MCID) for patient-reported outcome (PRO) instruments used in orthopaedic device-related procedures in a workshop November 27-28, 2012. The goal is to “streamline evidence-based scientific rationales for regulatory guidance of clinical trials and device study design for gender, age and BMI factors.” Visit the workshop website for more information.

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