In its final document, the US FDA outlines its interpretations of the four criteria for excluding clinical decision support software from being regulated as medical devices under federal law. Software must meet all four criteria to be excluded.
In its final document, the US FDA outlines its interpretations of the four criteria for excluding clinical decision support software from being regulated as medical devices under federal law. Software must meet all four criteria to be excluded.
In this blog, we share our insights and experiences to help companies build quality, scalability, and flexibility into their regulatory writing. We hope you find it insightful. For questions, please contact info@criterionedge.com.
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