Medical device development is a highly regulated process that while complicated, does offer straightforward paths to marketing authorization. Ensuring that you are on the proper product development path will increase the likelihood of commercial success. This workshop will provide an overview on the various product development routes for medical devices. These include, pre-market notification (510K) and pre-market authorization routes. Emphasis will be placed on device classification, IDE preparation and, in the case of in vitro diagnostic tests, CLIA designation.
