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FDA Decisions and Changes
Date: February 01, 2011
FDA Decisions and Changes. OCTANe. One of the single biggest factors affecting medical device companies in 2011 will be the proposed changes to the FDA’s clearance and approval processes. The increased uncertaintly associated with the regulatory clearance and approval processes have negatively impacted investments in innovative new medical device technologies and the overall global competitiveness of the US medical device industry.This program will explore the landmark ReGen Biologics’s decision, proposed changes to the 510(k) clearance process, and the resultant impact to the Medical Device business. See
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