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Unformatted text preview: regulation Used to milk the companies – need some instrunment to protect the companies FDA – The amendment also contain a preemption provision specifying that no state may establish any requirement that is different from or contrary to those of the FDA 2 kinds of FDA approvals – pre-market approval – full scale, demand and cost Pre-market notification- if a slight improved on a device pre 1976 then no need to do the whole shebang Companies will likely to go through the full scale approval in order to gain preemption making a new regime in which pre-market approval brings preemption could encourage manufactures to channel to that process those devices that are most likely to prompt tort litigation....
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This note was uploaded on 06/30/2010 for the course CAT cat 2 taught by Professor Golan during the Spring '10 term at UCSD.
- Spring '10