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Regulatory & Policy

News COMMISSION RECOMMENDATION
01 Sep 2013
News US FDA Updates Plans for UDI and Post-Market Surveillance System
05 Apr 2013
News IMDRF Recommendations for UDI Systems
01 Apr 2013
News Europe's Proposed Medical Device Regulation
01 Mar 2013
News eIFU from 1st March 2-13 - European Commission Regulation (EU) No 207/2012
01 Feb 2013
News Scientific Disagreements Regarding Medical Device Regulatory Decisions
01 Jun 2012
News Factors to consider when making benefit-risks determinations in Medical Device Pre-market approval and De Novo classifications
01 Mar 2012
News New Borderline & Classification Medical Device document
09 Apr 2012
News MEDDEV 2.1/3 Rev3
08 Apr 2012
News MEDDEV 2.12-1 Rev6
07 Apr 2012
News Medical Device Directive
06 Apr 2012
News Medical Device Directive
05 Apr 2012
News Medical Device Directive
05 Apr 2012
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Scientific Disagreements Regarding Medical Device Regulatory Decisions 01 Jun 2012

The FDA plays a critical role in ensuring the safety and effectiveness of medical devices and other products.  At the Center for Devices and Radiological Health (CDRH), a series of scientific disagreements received media attention between 2008 and 2010.  In these instances, CDRH reviewers and their managers disagreed over whether medical devices under review met applicable review standards.

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