Programas formativos altamente qualificados para a Indústria Farmacêutica
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ÚLTIMAS NOTICIAS
510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review
This guidance outlines FDA's current thinking on key aspects of the 510(k) Third Party Review Program and third party review of Emergency Use Authorization (EUA) requests by describing FDA's expectations for the review of 510(k) submissions and EUA requests by third...
Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions
FDA is issuing this guidance to provide recommendations for predetermined change control plans (PCCPs) tailored to artificial intelligence (AI)-enabled devices. The recommendations in this guidance are intended to support iterative improvement through modifications to...
Total Product Lifecycle Considerations for Generative AIEnabled Devices
While interest in generative artificial intelligence (GenAI) tools across the health care sector has expanded rapidly, there remain open questions on the approach to regulating GenAI-enabled products that may fall within FDA’s jurisdiction, including, but not limited...
MDCG 2024-15 – Guidance on the publication of the clinical investigation reports and their summaries in the absence of EUDAMED (November 2024)
Article 77(5) MDR requires that the sponsor submits to the Member States in which a clinical investigation was conducted a clinical investigation report within one year of the end of the clinical investigation or within three months of the early termination or...
