Foley & Lardner LLP Partner Kyle Faget’s October interview with MedTech Insight is highlighted in their article, “Digital Health Regulations: A Year in Review,” which summarizes both the changes in digital health regulations in 2022 and what medical devices companies should look out for in the coming year.
Faget commented on the impact of the U.S. Food and Drug Administration’s (FDA) Clinical Decision Support Software (CDS) document, saying that some companies had to reevaluate whether their CDS products qualified as a device under the new guidance as the FDA took a broader approach to regulating that what was in its jurisdiction.
To read more about Faget’s earlier comments on this topic, click here.
