Reassessing Pre-market Regulation of Class III Medical Devices

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Reassessing Pre-market Regulation of Class III Medical Devices

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Title: Reassessing Pre-market Regulation of Class III Medical Devices
Author: Zollinger, Geri
Citation: Reassessing Pre-market Regulation of Class III Medical Devices (2003 Third Year Paper)
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Abstract: Regulation of medical devices has evolved over the past twenty-five years. Initially, Congress created a regime where the safety and efficacy of all medical devices would be reviewed to varying degrees, depending on the risk posed by the device. Class III devices, the most dangerous class of devices, were to each have a safety and efficacy review. To permit new market entrants on similar grounds as those marketing devices prior to the 1976 Amendments, Congress also created a premarket notification program, under which new devices were regulated in the same way as the pre-Amendment counterparts. However, the premarket notification program has evolved and taken over market authorization for all devices, including Class III devices. This paper argues that the premarket notification program has changed so much that it should be entirely eliminated for Class III medical devices.
Terms of Use: This article is made available under the terms and conditions applicable to Other Posted Material, as set forth at http://nrs.harvard.edu/urn-3:HUL.InstRepos:dash.current.terms-of-use#LAA
Citable link to this page: http://nrs.harvard.edu/urn-3:HUL.InstRepos:8852137

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