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FDA 发布《564 条款宣布的突发公共卫生事件期间部分体外诊断器械的验证》最终指南
原文摘要
FDA 于 11 月 10 日在 Federal Register 发布最终指南《Validation of Certain In Vitro Diagnostic Devices for Emerging Pathogens During a Section 564 Declared Emergency》（Docket No. FDA-2024-D-2707）。