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International Medical Device Regulatory Monitor
May 2012 | Vol. 20 No. 5
European Parliament Calls for Premarket Authorization System in Wake of PIP
As fallout from the defective PIP breast implant imbroglio continues, a European Parliament health committee is calling for tough new regulatory controls, including the creation of a premarket authorization system for certain categories of medical devices — an idea that brought immediate kickback from industry.
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