US Regulatory Reads, June 2018: More Maturity, Compliance And Trade
Our ongoing feature series on the appraisal of manufacturing capability and maturity in the medtech space continued to capture major attention from readers in June, as did Medtech Insight's always-popular Compliance Corner pieces. Also popular last month: the Trump administration's tariff plans, guidewire policies and digital health.
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The US agency sent a letter to health-care providers spotlighting its analysis of the increasing numbers of adverse events linked to surgical staplers and implantable staples, and its plans for a draft guidance on labeling and an advisory panel meeting to consider a 510(k) requirement for the products.
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.