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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dc.contributor.advisor Hutt, Peter Barton en_US
dc.contributor.author Zollinger, Geri en_US
dc.date.accessioned 2012-06-07T20:16:02Z
dc.date.issued 2003 en_US
dc.identifier.citation Reassessing Pre-market Regulation of Class III Medical Devices (2003 Third Year Paper) en
dc.identifier.uri http://nrs.harvard.edu/urn-3:HUL.InstRepos:8852137
dc.description.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. en
dc.language.iso en_US en
dash.license LAA en_US
dc.subject Food and Drug Law en
dc.subject medical devices en
dc.subject pre-market en
dc.subject regulation en
dc.title Reassessing Pre-market Regulation of Class III Medical Devices en
dc.type Paper (for course/seminar/workshop) en_US
dc.date.available 2012-06-07T20:16:02Z

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