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 effectiveness have been established. Although this complex system is the result of a societal decision to ensure device safety and effectiveness, it has the potential to delay product marketing and impede innovation. Medical device regulation recently has undergone major changes with the enactment of the Food and Drug Administration Modernization Act of 1997 (FDAMA), legislation that is intended to increase system efficiency while retaining the requirement of safety and effectiveness. However, many of the envisioned improvements 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 history of productive dialogue with the FDA to transform the legislative vision of FDAMA into regulatory reality. Such action will ensure timely access to the new device technologies that are necessary for the growth of our specialty and the effective care of our patients.
Smith
J J
JJ
Department of Radiology, Massachusetts General Hospital, 55 Fruit St, Boston, MA 02114, USA. smith.john@mgh.harvard.edu
D018795:Device Approval / Q000331:legislation & jurisprudence* / Q000592:standards*; D004869:Equipment Safety / Q000592:standards; D006801:Humans; D013679:Technology, Radiologic / Q000295:instrumentation* / Q000592:standards*; D014481:United States; D014486:United States Food and Drug Administration