Exacerbated by recalls and other issues in recent headlines, medical device companies operating on a global basis face an expanding set of legal and regulatory risks and concerns around product safety. Scrutiny from the public and regulators is increasingly focused on ensuring product safety, as demonstrated by FDA funding increases to CDRH (the Center for Devices and Radiological Health) and launch of the Sentinel Initiative, a national electronic system that will transform FDA’s ability to track the safety of drugs, biologics, and medical devices.

Even though CDRH postponed dealing with recommendations on postmarket surveillance studies until after the Institute of Medicine issues its report on the 510(k) process later this year, their 2011 Strategic Priorities include plans to increase near real-time adverse event reporting from healthcare providers and put into place mechanisms to further harmonization efforts and exchange medical device information with foreign regulatory authorities. Outside the US, device companies face new EU device regulations, and other countries are focusing on increasing transparency and accountability.

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