Regulatory News In Brief
This article was originally published in The Gray Sheet
Executive Summary
IMDRF releases three new proposed guidance documents. FDA is accepting comments on its plans to accept electronic submissions for device recalls. More regulatory news.
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Research Briefs: Underreporting Robot Surgery Events; AFib, Lung-Cancer Studies
A review of court records and media reports finds several robotic surgery adverse event reports that do not appear in FDA’s public records. DECAAF shows DE-MRI can guide atrial fibrillation ablation. The PanCan study identifies predictors of lung cancer.
Pressure On Hysterectomy Procedures Challenges Intuitive’s Financials
The robotic surgical instrument company attributes the decline in capital equipment sales to disappointing growth in benign gynecology procedures performed in the U.S. with the firm’s flagship da Vinci robot.
Medtronic Petitions FCC To Expand Medical Testing License Eligibility
In a petition to the Federal Communications Commission, Medtronic asked the agency to expand medical testing license eligibility to sponsors of clinical trials, as well as clarify its policy on manufacturers recovering costs for clinical studies.