Kyle Faget Interviewed on Classification of Clinical Decision Software Following New FDA Guidance

Foley & Lardner LLP Partner Kyle Faget is interviewed in the MedTech Insight article, “Expert: New Guidance May Demand Clinical Decision Support Software Re-Evaluation,” detailing the need for businesses to reevaluate the classification of their clinical decision software (CDS) based on new Food and Drug Administration (FDA) guidance.

Faget noted that the final guidance differs significantly from the FDA draft, making it imperative for CDS manufacturers to understand this development.

“If you are a developer, and you did your analysis based on the 2019 draft guidance, you better go back and do that assessment anew to make sure that whatever conclusions you made, using that relying upon that 2019 draft guidance that those conclusions are still valid under the 2022,” Faget said.

The final guidance takes a “broader approach to what’s rightfully in [the FDA’s] jurisdiction for regulation,” Faget said, adding that this might cause pushback from the industry, “It’s going to be a heavier lift [for CDS manufacturers] than for developers that are developing in the direct-to-consumer space.”

Faget’s comments also appeared in the February 2023 MedTech Insight article, “Petition Argues FDA’s CDS Software Guidance Violates The Law.” 

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