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Regulatory News In Brief

FDA issues guidance documents on PMA and 510(k) user fees and refunds. Agency issues proposed order for three pre-amendment devices. More regulatory news.

FDA is inviting stakeholders to discuss the development of an international consortium of cardiovascular registries at a public meeting April 22 in Silver Spring, Md. The agency says it plans a pilot phase for the project focused on “developing relationships and analysis strategies for transcatheter cardiac valve registries.” The initial efforts focused on linking transcatheter valve registries “would be expanded to additional cardiovascular devices in the future,” FDA says.

Topics to be discussed at the meeting include the role of registry consortia in post-market surveillance; goals of the international consortium of cardiovascular registries; analysis of near- and long-term outcomes...

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