After strong pushback to a clinical decision support (CDS) software draft guidance, it seems the US agency has decided to heed industry concerns to take a more risk-based approach by issuing another draft of the guidance. Industry sources are applauding the FDA's move, saying it gives them another opportunity to fine-tune the regulations, which could mean fewer CDS manufacturers would be regulated by the agency.
Almost two years after publishing a controversial draft guidance on clinical decision support (CDS) software, the US Food and Drug Administration is taking another stab at the issue with an updated draft guidance to the delight of industry stakeholders.
On 26 September, the agency released the Clinical Decision Support Software guidance – a revised version of a document published by the FDA in December 2017 that was met...
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Fujirebio Diagnostics' Alzheimer's disease test, Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio, has been cleared by the US FDA.
