Reassessing Pre-market Regulation of Class III Medical Devices

Reassessing Pre-market Regulation of Class III Medical Devices

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Reassessing Pre-market Regulation of Class III Medical Devices

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