Regulation of medical devices in radiology: Current standards and future opportunities

Today's radiology community depends heavily on cutting-edge diagnostic and therapeutic medical devices to serve patients. These products are regulated by the U.S. Food and Drug Administration (FDA) under a system that grants marketing approval for only those indications for which the safety and effe ctiveness have been established. Although this complex system is the result of a societal decision to ensure device safety and effectiveness, it has t he potential to delay product marketing and impede innovation. Medical devi ce regulation recently has undergone major changes with the enactment of th e Food and Drug Administration Modernization Act of 1997 (FDAMA), legislati on that is intended to increase system efficiency while retaining the requi rement of safety and effectiveness. However, many of the envisioned improve ments cannot occur without cooperative interaction between stakeholders in the device development process, including the FDA and the clinical medicine community. The radiology field must continue to build on its strong histor y of productive dialogue with the FDA to transform the legislative vision o f FDAMA into regulatory reality. Such action will ensure timely access to t he new device technologies that are necessary for the growth of our special ty and the effective care of our patients.