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The FDA approval process for medical devices: an inherently flawed system or a valuable pathway for innovation?
  1. Kyle M Fargen1,
  2. Donald Frei2,
  3. David Fiorella3,
  4. Cameron G McDougall4,
  5. Philip M Myers5,
  6. Joshua A Hirsch6,
  7. J Mocco7
  1. 1Department of Neurosurgery, University of Florida, Gainesville, Florida, USA
  2. 2Department of Interventional Neuroradiology, Radiology Imaging Associates, Englewood, Colorado, USA
  3. 3Department of Neurological Surgery, State University of New York - Stony Brook, Stony Brook, New York, USA
  4. 4Department of Neurological Surgery, Barrow Neurological Institute, Phoenix, Arizona, USA
  5. 5Department of Neurosurgery, Columbia University, New York, New York, USA
  6. 6Neuroendovascular Program, Massachusetts General Hospital, Boston, Massachusetts, USA
  7. 7Department of Neurosurgery, Vanderbilt University, Nashville, Tennessee, USA
  1. Correspondence to Dr Kyle Michael Fargen, Box 100265, Gainesville, FL 32610, USA; kyle.fargen{at}neurosurgery.ufl.edu

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Introduction

Medical devices, developed through physician and industry partnerships, have helped to revolutionize the treatment of disease spanning most medical disciplines. This includes such entities as deep brain stimulation implants for Parkinson's disease, knee replacements for osteoarthritis, coil embolization technologies for intracranial aneurysms and implantable cardiac defibrillators for life-threatening arrhythmias. These remarkable products have undeniably led to increased patient longevity and improved quality of life. Such marvels of modern medicine, however, do not come without cost, to either the consumer or the manufacturer. Recent estimates suggest that the annual expenditures on medical devices in the USA approximates $95–150 billion, which represents almost one-half to three-quarters of the $200 billion spent on such devices across the world and about 6% of our total national health expenditures.1 ,2 Development of new technologies requires considerable investment from companies in terms of research and development costs, manufacturing and marketing, as well as a rigorous approval process through the Food and Drug Administration (FDA). All-in-all, the price of innovation is monumental for those invested in advancing medicine through cutting edge technologies. Recently, there has been a push among lobbyists representing device manufacturers to streamline the lengthy FDA approval process,3 arguing that the USA will lose its ability to compete globally due to the excessive costs and delays in obtaining FDA approval.

However, in direct contrast to any effort to ‘streamline’ the approval process, the oversight of device innovation and the approval process has been criticized recently due to several notable device ‘failures’ that have been linked to patient harm. These devices were approved for use through FDA humanitarian device exemption (HDE) or 510(k) processes, which do not require randomized controlled trial evidence demonstrating safety and effectiveness prior to …

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