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

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2026-05-04
- Length: 18m
- Episode: 458
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-05-04-458-what-the-fda-actually-says-about-ai-in-medical-devices
- Listen: https://podcast.greenlight.guru/episode/what-the-fda-actually-says-about-ai-in-medical-devices

## Summary

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).

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-05-04-458-what-the-fda-actually-says-about-ai-in-medical-devices#t=0) Introduction: The FDA's Use of Elsa and the AI Paradigm Shift

## Topics

- [AI & machine learning](https://hardwarepodcasts.com/topic/ai-and-machine-learning)
- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)

## Most relevant to

large enterprises

## Mentioned

- Elsa (tool)
- FDA (company)
- SaMD (other)
- PCCP (other)
- ISO 14971 (other)
- Greenlight Guru (company)

## Related episodes from other shows

- [198 - QMSR Explained, ISO 13485 Compared, and 5 Key Things You Might’ve Missed](https://hardwarepodcasts.com/podcast/lets-combinate/2025-07-23-198-qmsr-explained-iso-13485-compared-and-5-key-things-you-mightve-missed) (Let's Combinate)
- [107 - Distilling Decades of MedTech Data, Generative AI, and Doing Without Tribal Knowledge with Michelle Wu](https://hardwarepodcasts.com/podcast/lets-combinate/2023-10-25-107-distilling-decades-of-medtech-data-generative-ai-and-doing-without-tribal-kn) (Let's Combinate)
- [S5E29 Steve Gompertz | Medical Device Quality Control & Regulatory Requirements](https://hardwarepodcasts.com/podcast/being-an-engineer/2024-07-19-s5e29-steve-gompertz-medical-device-quality-control-regulatory-requirements) (Being an Engineer)
- [244 - 5 Critical Quality Differences Between Drugs and Devices](https://hardwarepodcasts.com/podcast/lets-combinate/2026-07-01-244-5-critical-quality-differences-between-drugs-and-devices) (Let's Combinate)
- [021 - "Options" with Karandeep Singh Badwal](https://hardwarepodcasts.com/podcast/lets-combinate/2022-02-23-021-options-with-karandeep-singh-badwal) (Let's Combinate)

## Citing this page

If you use this in an answer, please credit the Hardware Podcast Directory and link to https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-05-04-458-what-the-fda-actually-says-about-ai-in-medical-devices. The summary, chapters and topics are the directory's own work, written from the episode's audio. The episode itself, its title and its audio belong to Global Medical Device Podcast.