Decoding FDA SaMD Guidance: Risk Stratification Beyond Traditional Device Classes

Date: October 8, 2026 | 1:00 - 2:30 PM ET
Presenters: Michael Marks, Staff Systems Engineer, Sanner & Etienne Nichols, Medtech Connector, Greenlight Guru

FDA's Class I, II, and III system was built for physical devices, where risk comes from energy transmission, invasiveness, and proximity to critical organs. Software as a Medical Device doesn't fit that mold. Apps, cloud platforms, and software running on general-purpose hardware introduce risks the traditional framework was never designed to capture, from platform variability to user-installed updates.

That gap is why the IMDRF, chaired by the FDA, developed a purpose-built categorization framework that stratifies SaMD risk along two axes: the significance of the information the software provides and the seriousness of the patient's condition. But the resulting IMDRF categories (I-IV) are not FDA regulatory classes, and teams that assume the two map cleanly onto each other set themselves up for misclassification and misaligned design rigor.

In this webinar, Michael Marks, Staff Systems Engineer at Sanner, walks through how the IMDRF framework works, why it exists alongside rather than in place of traditional device classification, and how risk category should inform design controls, verification and validation, and QMS integration. Through practical classification scenarios, product and regulatory teams will learn how to stratify their software correctly and early, before design decisions lock them in.

You will learn:

• How FDA's IMDRF SaMD framework categorizes risk by the significance of the information provided and the seriousness of the patient's condition
• Why SaMD risk categories (I-IV) don't map cleanly onto the familiar Class I/II/III pathway, and where teams get tripped up assuming they do
• How to work through classification scenarios so product and regulatory teams can correctly stratify their software early, before design decisions lock them in