PMA Application Methods - Traditional PMA

A PMA application involves many volumes of material to be submitted to FDA. The volumes include device description and intended use, nonclinical and clinical studies, case report forms, manufacturing methods, labeling, etc. In the traditional PMA method, the complete PMA application is submitted to FDA at once. This method is generally used if the device has already undergone clinical testing and has been approved in a country with established medical device regulations. FDA has established methods of early collaboration with the sponsor allowing devices to brought to market as early as possible. These methods include the Modular PMA, Streamlined PMA, and Product Development Protocol and are discussed below.