Global IVD Regulations and Submissions

Catalog description

Examines in-depth regulations governing in vitro diagnostic medical devices. Covers 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—these countries could include China, Brazil, Mexico, etc. 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. Covers emerging trends in IVDs, such as the advent of companion diagnostics and their relationship to personalized medicine.