This three-part publication examines various aspects of the US Food and Drug Administration (FDA) premarket approval application (PMA) process, which is the regulatory pathway for the introduction of Class III medical devices into commercial distribution in the USA.

Part one is devoted to performing a descriptive and statistical analysis of the PMA process based on information contained in the FDA PMA database for PMA applications from the years 2003 through 2007 inclusive.

Part two is devoted to performing a descriptive and statistical analysis comparing the PMA process to the European Union CE marking approval process in an effort to identify the potentially superior system.

Part three describes and analyses the reasons why, historically, US PMA applications have been found to be not approvable by the FDA. The research found that from December 2002 through to the time that the research was conducted in 2007, there were seven PMA applications that were disapproved by the FDA based in part on disapproval recommendations by the FDA appointed scientific Advisory Panels. Of these seven PMA applications, five of the devices were found to have received prior European CE marking.

These three articles have previously been published in the November 2007, February 2008 and August 2008 issues of the Journal of Medical Device Regulation, respectively.

Specification: 49 pages plus covers, in English, supplied by email as a PDF.