US Regulatory Reads, January 2019: Risk Management, 510(k) Reforms And The Shutdown
The partial government shutdown left a major shadow on the medtech regulatory world for much of January, but there also were several other important substantive issues addressed by MTI last month that did not escape Medtech Insight readers' attention. A look at the top stories from the month.
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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of the increasing numbers of adverse events linked to surgical staplers and implantable staples, and its plans for a draft guidance on labeling and an advisory panel meeting to consider a 510(k) requirement for the products.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.