RGA 6690 — Global In Vitro Diagnostic Regulations and Submissions
3 semester hoursGraduateLecture
Examines in-depth the regulations governing in vitro diagnostic medical devices. Studies the IVD regulations for the four major economic markets—United States, European Union, Australia, and Canada—as well as other markets that have specific IVD regulations, possibly including China, Brazil, and Mexico. Topics include IVD classification schemes, regulatory strategy, regulatory submission routes (including harmonization), regulatory review processes, performance evaluation, clinical trial requirements, labeling, and postmarketing. Also explores IVD testing methodologies and emerging trends in IVDs.