frank39.. I think i understand what you're saying.. we do know that the FDA is going to restrict the usuage of the machine. we've been told that.. and we've been told future modifications will be made.. We've been told that nuerological is one use that it cannot be used for. 3D would be perfect in trauma centrs for head wounds, but wil be restricted. What else is restricted? Can it be used to observe organs under the present label? The label prevents it from being used for certain functions. What functions? I'm sure buyers will want to know.. maybe i'm missing something and barking up the wrong tree, but we don;t really know what it can be marketed to do. Thanks in advance to anyone that know the answers...
i had had this article saved on another pc of mine and happened acrossed it the other day... it is dated 2001, but i think it is written well enough to give those not too familiar with the process/concepts some good insights...a good "primer" or tutorial if you will... it relates directly to radiology and is a smooth read... REMEMBER the DViS is class II.
Regulation of Medical Devices in Radiology: Current Standards and Future Opportunities1
John J. Smith, MD, JD + Author Affiliations
1From the Department of Radiology, Massachusetts General Hospital, 55 Fruit St, Boston, MA 02114; Harvard Medical School, Boston; and the Center for Integration of Medicine and Innovative Technology, Boston. Received August 31, 1999; revision requested October 21; revision received November 19; accepted December 17. Supported in part by a grant from the Center for Innovative Minimally Invasive Therapy, a nonprofit consortium consisting of Massachusetts General Hospital, Brigham and Women’s Hospital, Massachusetts Institute of Technology, and Draper Laboratory. Address correspondence to the author (e-mail: smith.john@mgh.harvard.edu).
Abstract
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.
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