FDA 510(k) e marca CE (IVDR) para analisadores de CBC: Dois sistemas regulamentares distintos - como navegar em ambos
Regulatory approval is essential but structurally different across the US and EU for CBC analyzer suppliers. The FDA’s 510(k) pathway and EU’s IVDR CE marking system employ distinct procedural architectures, evidence requirements, and governance models—not simply varying speeds for the same goal. FDA 510(k) achieves clearance via predicate-device equivalence in 4–12 months (if strong predicates […]


