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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its annual guidance priorities in mid-October, listing 18 guidance topics designated as “A-list” or “B-list” final or draft guidance priorities.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.
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.
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.
The TCT MedTech Innovation Forum focused on the business side of innovation. Excerpted from MedTech Strategist's recent feature article.