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Recent Posts Renewal Season is Here! FY 2027 Device Establishment Registration and Listing October 20, 2026 CDRH’s FY 2027 Proposed Guidances: Shorter Lists, Focused on Software and AI October 18, 2026 CMS Gains Permissive Exclusion Authority: Implications for Pharma and Medical Device Companies October 16, 2026 Rare Disease Refresh: FDA’s Rare Disease Framework Initiative October 14, 2026 “Biennial” v.

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