# #328 FDA Guidance on Artificial Intelligence (AI) in Medical Devices

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2023-07-20
- Length: 50m
- Episode: 328
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-07-20-328-fda-guidance-on-artificial-intelligence-ai-in-medical-devices
- Listen: https://podcast.greenlight.guru/episode/328-fda-guidance-on-artificial-intelligence-ai-in-medical-devices

## Summary

Mike Drues, President of Vascular Sciences, discusses the FDA's April 2023 draft guidance on Predetermined Change Control Plans (PCCP) for Machine Learning Enabled Device Software Functions (ML-DSF). He explains that PCCPs allow AI software to evolve within pre-validated boundaries, replacing the restrictive 'locked algorithm' concept. Drues emphasizes that regulatory logic remains consistent with traditional change management, using examples like surgical cauterizers to illustrate how software can autonomously adjust parameters like temperature while maintaining safety and efficacy.

## Outline

1. Introduction: Mike Drues and the History of AI in Medical Devices
2. Defining AI and the Problem with Locked Algorithms
3. The Predetermined Change Control Plan (PCCP) Solution
4. Practical Examples: Cauterizers and Autonomous Learning
5. Labeling, Adjunct Claims, and Regulatory Burden
6. Validation Challenges and Statistical Complexity
7. Predicate Devices, De Novo, and Marketing Labeling
8. Final Advice: Regulatory Logic and FDA Engagement

## Topics

- [Connected products & IoT](https://hardwarepodcasts.com/topic/connected-products-and-iot)
- [Validation & product-market fit](https://hardwarepodcasts.com/topic/validation-and-product-market-fit)
- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Medical & health devices](https://hardwarepodcasts.com/topic/medical-devices)

## Most relevant to

early-stage companies

## Mentioned

- Vascular Sciences (company)
- Greenlight Guru (company)
- FDA (company)
- PCCP (other)
- ML-DSF (other)
- 510K (other)
- De Novo (other)

## Related episodes from other shows

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- [134 - ISO62304, Software Development Process, SaMD, Closed Loop Systems, Complexities with Cloud and Better Software in MedTech with Richard Koch](https://hardwarepodcasts.com/podcast/lets-combinate/2024-05-01-134-iso62304-software-development-process-samd-closed-loop-systems-complexities) (Let's Combinate)
- [094 - Connected Combination Products, Product Traceability, Regulating New Products, Pre-Determined Changes and AI/ML with Rumi Young](https://hardwarepodcasts.com/podcast/lets-combinate/2023-07-19-094-connected-combination-products-product-traceability-regulating-new-products) (Let's Combinate)
- [206 - Will AI Decide Your Next Drug/Device Approval?](https://hardwarepodcasts.com/podcast/lets-combinate/2025-09-17-206-will-ai-decide-your-next-drug-device-approval) (Let's Combinate)
- [143 - New FDA Draft Guidance: Essential Drug Design Outputs with Alan Stevens and Rumi Young](https://hardwarepodcasts.com/podcast/lets-combinate/2024-07-03-143-new-fda-draft-guidance-essential-drug-design-outputs-with-alan-stevens-and-r) (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/2023-07-20-328-fda-guidance-on-artificial-intelligence-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.