In this first episode of Medtech Connect, Medtech Insight’s regulatory reporter Hannah Daniel interviews Foley and Lardner partner Kyle Faget about the complexities behind regulating software as a medical device (SaMD). Many companies are unsure if their software is even regulated by the FDA, let alone how to go about the approval process. From managing cybersecurity risks to navigating digital health policy, Faget does it all, and she gives us insight into the regulatory landscape of SaMD in this month’s episode.

Medtech Connect Episode 1: How Do We Regulate Software As A Medical Device?

The regulatory grey zone for digital health in the European Union has finally cleared. In a landmark move, the EU's Medical Device Coordination Group (MDCG) has issued the MDCG 2025-4 Guidance, a document that fundamentally reshapes the responsibilities for medical device software (MDSW) and Software as a Medical Device (SaMD) distributed through major online platforms.

MDCG 2025-4  Medical Device Software Apps on Online Platforms

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New tracks tagged #SamD