US Regulatory Roundup, August 2018: 'Bleeding Edge' Response, Quality System Regulation Rewrite Forecast, And More
Our interviews with AdvaMed's chief about a documentary that is highly critical of industry and with global device expert Kim Trautman about the planned mash-up of US FDA's Quality System Regulation and international standard ISO 13485 were Medtech Insight's most popular articles last month.
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On the latest Medtech Insight podcast, David Filmore and Ferdous Al-Faruque discuss the unexpected news that Scott Gottlieb is leaving US FDA next month. What has been his legacy for medtech, and who will replace him?
The commissioner says he will step down next month, leaving a legacy of active policy development, but also a lot of initiatives and pilot projects that are in the middle of being implemented.