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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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US FDA Updates Plans for UDI and Post-Market Surveillance System 05 Apr 2013

The US Food and Drug Administration has published a report updating its plans for a nationwide medical device post-market surveillance system, including implementation of a Unique Device Identification (UDI) framework.

The FDA report coincides with the release of new UDI guidelines by the International Medical Device Regulators Forum (IMDRF), as well as European Commission recommendations for an EU-wide UDI system. As expected, both US and EU regulators have based their proposed systems largely on the IMDRF recommendations, boding well for a harmonized UDI system on a global—or at least international—scale.

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