Expert: New Guidance May Demand Clinical Decision Support Software Re-Evaluation
Businesses should reevaluate the classification of their clinical decision software based on a new FDA guidance, Kyle Faget of Foley & Lardner LLP tells Medtech Insight.
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FDA Publishes Final Guidance On Clinical Decision Support Software, Clarifies What Software Should Be Regulated As Medical Devices
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.