Hardware Podcasts

#458: What the FDA Actually Says About AI in Medical Devices

Global Medical Device Podcast · 4 May 2026 · 18m · Episode 458

What this episode covers

Etienne Nichols explains how the FDA's adoption of its internal AI tool, Elsa, signals that AI in medical devices is a regulated reality requiring strict adherence to new standards. He argues that companies should view AI like electricity, focusing on building a robust Quality Management System (QMS) rather than marketing the technology itself. Nichols details the regulatory distinctions between locked and adaptive algorithms, emphasizing the critical role of Predetermined Change Control Plans (PCCPs) and post-market surveillance for AI-based Software as a Medical Device (SaMD).

Most relevant to

large enterprises

Topics

Mentioned

Companies
FDA, Greenlight Guru
Tools
Elsa
Also
SaMD, PCCP, ISO 14971

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