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In this week’s Pathways Picks: CMS-FDA RAPID proposal could be out this month; FDA issues draft guide on payor communications, and final guidance on human factors testing; China establishes standard framework for reclassifications; South Africa outlines what’s expected for electronic instructions for use; and more from South Korea, Europe, and the US.
Watchful waiting has hitherto been the best course for smaller abdominal aortic aneurysms, although they are likely to grow, and could unexpectedly rupture. There is hope on the horizon; Nectero recently published two-year FIH data, and Angiolutions emerges with what its founders call a first-in-class mechanobiological device strategy.
FDA plans to exempt more unclassified devices from premarket notification requirements. Excerpted from Pathways’ Picks June 11: Opposition to EU WET Exemptions, Medicare Coverage Updates, and More.