CDRH issued its annual guidance priorities in mid-October, listing 18 guidance topics designated as “A-list” or “B-list” final or draft guidance priorities. Excerpted from Pathways' Picks October 19: CMS Rules, EU Meet-Up, FDA Guides, UK Picks and More.
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Some takeaways from FDA's FY 2022 report on the Breakthrough Device program. Excerpted from Pathways' Picks November 2: Medicare Pay, Breakthrough Stats, CE Mark Times, and More.
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FDA has officially unveiled its new TPLC Advisory Program pilot, with an initial focus on cardiovascular devices. Excerpted from Pathways' Picks October 12: AP Time, EU Positions, CMS Principles, and More.
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The TCT MedTech Innovation Forum focused on the business side of innovation. Excerpted from MedTech Strategist's recent feature article.