R.M. Ruedy b b Vice President, Regulatory, Clinical and Quality Affairs Cardica, Inc. Redwood City, Calif Without approval for marketing by the US Food and Drug Administration (FDA), even the most brilliant new medical device has essentially no economic value. Any strategy for bringing a novel device to the market must focus on the "regulatory pathway." The federal government has developed several such pathways, the choice of which has substantial effect not only on the expense required to gain approval but also on how the device can later be marketed and used. We suspect that many interventional neuroradiologists pay little attention to the nuances of "regulatory pathways." However, the advisability of regulatory naïveté has diminished with the advent of the now often-used "Humanitarian Device Exemption (HDE)" regulatory pathway. 1 It is the purpose of this paper to briefly review the HDE regulatory pathway and, more importantly, to focus the physician on the constraints, regulations, and practitioner responsibilities associated with these Humanitarian Use Devices (HUDs). Regulatory Pathways In general, there are 4 primary methods for marketing a medical device, including premarket approval (PMA)/product development protocol (PDP), premarket notification (510(k)) clearance, exempt devices, and HDE. The FDA defines several "classes"
American Journal of Neuroradiology – American Journal of Neuroradiology
Published: Feb 1, 2009