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FDA regulation of new devices-expedited review

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1 Author(s)
E. J. Flannery ; Covington & Burling, Washington, DC, USA

The expedited review and approval of new medical devices by the US Food and Drug Administration (FDA) is described within the context of ethical issues in the regulation of new technologies. Current statutory provisions governing approval of medical devices, and the way in which the FDA has implemented these provisions are examined. Administrative efforts by the FDA to increase both the quality and efficiency of the new-product review process are then discussed.<>

Published in:

IEEE Engineering in Medicine and Biology Magazine  (Volume:7 ,  Issue: 2 )