US Regulatory Reads, 2017: Inspection Tips, Experimentation, And Trump
Executive Summary
2017 was obviously dominated by news of political chaos coming out of the White House and, for the medtech industry, the year was bookended by its failure to win repeal of the medical device tax. But last year was an extremely fruitful period for new US FDA policies, pilot programs and other approaches intended to streamline the scrutiny of devices. Medtech Insight readers couldn't get enough of coverage and insights on US FDA inspections and compliance topics, which dominated our top 25 most popular US regulatory and policies stories for last year. Also making the list were pieces delving into the evolving, and very active, FDA under Scott Gottlieb, the agency's growing attention to digital health, and the impact of the Trump administration's deregulation emphasis.
You may also be interested in...
FDA Eyes Upclassification, Labeling Guidance To Address Stapler Risks
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of the increasing numbers of adverse events linked to surgical staplers and implantable staples, and its plans for a draft guidance on labeling and an advisory panel meeting to consider a 510(k) requirement for the products.
Device Week, March 8, 2019 – Scott Gottlieb Resigns
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?
Scott Gottlieb Calls It Quits After An Active Tenure At US FDA
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.