USA – Existing software development lifecycle tools can help speed AI/ML products to market
Software developers creating artificial intelligence/machine learning (AI/ML) medical products should move forward with the software development lifecycle (SDLC) models they are already familiar with...
USA – AdvaMed calls for changes to FDA’s non-spinal bone fixation device guidance
The medtech lobby group AdvaMed has asked the US Food and Drug Administration (FDA) to make changes to its recent guidance on orthopedic non-spinal...
USA – Considerations for the Conduct of Clinical Trials of Medical Products During Major...
This guidance recommends approaches that sponsors of clinical trials of medical products can consider when there is a major disruption to clinical trial conduct...
USA – FDA Denies Marketing of Logic’s Menthol E-Cigarette Products Following Determination They Do...
Today, the U.S. Food and Drug Administration issued marketing denial orders (MDOs) for several e-cigarette products currently marketed by Logic Technology Development LLC (Logic). The...
USA – FDA updates physiologic closed-loop control final guidance with industry feedback
The US Food and Drug Administration (FDA) has finalized guidance on physiologic closed-loop control (PCLC) technologies that includes several updates requested by medical device...
USA – New rule directs mammography facilities to tell patients about breast density
The US Food and Drug Administration (FDA) has issued a final rule intended to ensure patients are better informed about their breast tissue density...
USA – FDA updates third party 510(k) guidance
The US Food and Drug Administration (FDA) has published a draft guidance that updates a 2020 final guidance on its third party 510(k) review...
USA – FDA updates guidances to reflect new MDUFA goals
The US Food and Drug Administration has updated three guidances to reflect revised timelines for responding to premarket approval (PMA), 510(k) and de novo applications under...
USA – FDA advisors want standards, labeling to address racial disparities with pulse oximeters
A panel of external US Food and Drug Administration (FDA) experts are urging more research to improve the efficacy of pulse oximeters in people...
USA – FDA launches TAP Pilot to speed access to safe and innovative medical...
The US Food and Drug Administration announced that it has launched a pilot program designed to foster earlier conversations in the medical device product...
