US Regulatory Reads, April: TPLC; Cybersecurity; 23andMe
US regulatory and policy topics that attracted the most attention among Medtech Insight readers last month included looks at FDA device-center initiatives on the total product lifecycle and patient preferences; digital health compliance challenges; continued scrutiny of St. Jude Medical on cybersecurity; and more.
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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of the increasing numbers of adverse events linked to surgical staplers and implantable staples, and its plans for a draft guidance on labeling and an advisory panel meeting to consider a 510(k) requirement for the products.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.