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FDA Action Plan for AI/ML-Based SaMD FDA

FDA Action Plan for AI/ML-Based SaMD

The Food and Drug Administration (FDA), the US regulating authority in the sphere of medical devices and healthcare products has published an action plan on Software as a Medical Device (SaMD) based on the Artificial Intelligence / Machine Learning (AI/ML)...

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FDA Guidance on MDSAP Audit Approach FDA

FDA Guidance on MDSAP Audit Approach

The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of medical devices and healthcare products, has published detailed guidance dedicated to audits in the context of the Medical Device Single Audit Program (MDSAP). ...

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FDA Virtual Town Hall on COVID-19 Tests FDA

FDA Virtual Town Hall on COVID-19 Tests

The Food and Drug Administration (FDA), the US regulating authority in the sphere of medical devices, has published a transcript of the virtual town hall dedicated to the guidance on Coronavirus (COVID-19) diagnostic tests issued earlier by the Agency. The conference...

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