# #460: FDA AI Regulations: Master the QA/RA Skills to Stay Ahead

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2026-05-18
- Length: 15m
- Episode: 460
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-05-18-460-fda-ai-regulations-master-the-qa-ra-skills-to-stay-ahead
- Listen: https://podcast.greenlight.guru/episode/fda-ai-regulations-master-the-qa-ra-skills-to-stay-ahead

## Summary

Etsy Nichols discusses the evolving FDA regulatory landscape for AI-enabled medical devices, highlighting the establishment of the Digital Health Center of Excellence and the shift toward rigorous documentation over algorithmic sophistication. She outlines five guiding principles for AI/ML-based Software as a Medical Device (SaMD) and emphasizes the critical importance of Predetermined Change Control Plans (PCCPs) in bridging US and EU regulatory requirements. Nichols argues that QA/RA professionals must combine regulatory fluency with AI literacy to navigate these complex systems effectively.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-05-18-460-fda-ai-regulations-master-the-qa-ra-skills-to-stay-ahead#t=0) Introduction: FDA AI Regulation and Leadership Changes

## Topics

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

## Most relevant to

early-stage companies

## Mentioned

- FDA (other)
- Digital Health Center of Excellence (other)
- EU AI Act (other)
- EU MDR (other)
- PCCP (other)
- IMDRF (other)
- Piralia (company)

## Related episodes from other shows

- [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)
- [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)
- [256 - The New FDA Inspection Playbook: Where to Start with QMSR](https://hardwarepodcasts.com/podcast/lets-combinate/2026-09-28-256-the-new-fda-inspection-playbook-where-to-start-with-qmsr) (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)
- [172 - Regulatory AI Innovations, Drugs@FDA Database, Regulatory Intelligence Strategies, Human Factors Insights, and Smarter Submission Approaches with Doug Mead](https://hardwarepodcasts.com/podcast/lets-combinate/2025-01-22-172-regulatory-ai-innovations-drugs-fda-database-regulatory-intelligence-strateg) (Let's Combinate)

## Citing this page

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