Risk assessment and management as related to evaluation of medical devices: a view from the FDA

The regulatory management by the FDA of medical products should be thought of as a form of risk assessment and risk management. This is a new approach, a new way of thinking about product review and postmarket management processes. This paper outlines several aspects of risk assessment and management that have recently been incorporated into the FDA processes that will simplify reviews and lower the risks involved with the use of medical devices. These aspects include development of a new process for selecting the appropriate resources to dedicate to individual device applications, an increased emphasis on good experimental design for clinical studies, and continued development of a biomaterials database.