This course offers a clear and comprehensive view of the regulatory framework surrounding in vitro diagnostic (IVD) medical devices in the US.
Despite their technical recognition as a sub-class of medical devices, IVDs face different FDA expectations for pre- and post-market commercialization. This course provides detailed insight into this process, including applicable definitions, classification schemes, market trajectory, pre-market submissions, Clinical Laboratory Improvement Amendments (CLIA) categorization, quality system requirements, and post-market requirements for IVDs, as well as an introduction to the new sub-class of IVDs: companion diagnostics.
To enroll and purchase this course, please visit the WMDO website at: http://www.wmdo.org/SGS.aspx