US Regulatory News Briefs
Executive Summary
Updates on flu-assay regulation, an upcoming eye-care panel, and an FDA safety note on implantable infusion pump risks with MRI.
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FDA Panel Recommends Stricter Regulatory Standards For All Rapid Influenza Tests
FDA’s Microbiology Devices Advisory agrees with FDA’s proposals June 13 to move rapid flu antigen tests to class II with new sensitivity and specificity thresholds and post-market standards to address concerns with poor performance.
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of the increasing numbers of adverse events linked to surgical staplers and implantable staples, and its plans for a draft guidance on labeling and an advisory panel meeting to consider a 510(k) requirement for the products.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?