Pathways' Pick of the Week: 510(k) Guide Hat Trick
FDA drafts guidance on 510(k) predicates, clinical data, and implants. Excerpted from Pathways’ Picks September 6: 510(k) Guides, TAP Partners, and Digital Health.
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e-Newsletter BrowseFDA drafts guidance on 510(k) predicates, clinical data, and implants. Excerpted from Pathways’ Picks September 6: 510(k) Guides, TAP Partners, and Digital Health.
The UK launches an accelerated market access pilot pathway. Excerpted from Pathways Picks September 20: A Busy Week in Medtech Policymaking.
The UK launches an accelerated market access pilot pathway. Excerpted from Pathways Picks September 20: A Busy Week in Medtech Policymaking.
Health Canada has issued a draft guidance on premarket expectations for machine learning-enabled devices. Excerpted from Pathways’ Picks August 30: Canada Drafts Machine Learning Guide, Labs Speak Out, and More.