# #389: Pre-determined Change Control Plans

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2024-10-31
- Length: 44m
- Episode: 389
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-10-31-389-pre-determined-change-control-plans
- Listen: https://podcast.greenlight.guru/episode/389-pre-determined-change-control-plans

## Summary

Mike Drues, President of Vascular Sciences and former FDA consultant, discusses the Predetermined Change Control Plan (PCCP) with host Etienne Nichols. Drues explains how PCCPs allow manufacturers to get pre-approval for anticipated device changes within their original 510(k) or PMA submissions, a framework originally designed for AI-based Software as a Medical Device (SaMD) but now expanded to all medical devices. He highlights the regulatory logic behind pre-validating boundaries for changes, using examples like 3D-printed knees and in vitro diagnostics, while cautioning that the process requires significant upfront data and may not always save time or money compared to traditional special 510(k) submissions.

## Outline

1. Introduction to PCCPs and Change Management Options
2. Origins of PCCPs in AI and ML Devices
3. Expansion of PCCPs to All Medical Devices
4. Practical Challenges and Data Requirements
5. Submitting PCCPs: Structure and Best Practices
6. Potential of PCCPs for Non-Software Devices
7. FDA Guidance Limitations and Labeling
8. Final Recommendations and Quality System Implications

## Topics

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

## Most relevant to

established companies

## Mentioned

- Greenlight Guru (company)
- Vascular Sciences (company)
- FDA (other)
- 510(k) (other)
- PMA (other)
- SaMD (other)

## Related episodes from other shows

- [163 - ICH Q12, Established Conditions, Post-Approval Changes, PACMP's, and the Pharma Lifecycle](https://hardwarepodcasts.com/podcast/lets-combinate/2024-11-20-163-ich-q12-established-conditions-post-approval-changes-pacmps-and-the-pharma-l) (Let's Combinate)
- [239 - ICH Q12: What’s Binding? Established Conditions and Post-Approval Changes](https://hardwarepodcasts.com/podcast/lets-combinate/2026-05-27-239-ich-q12-whats-binding-established-conditions-and-post-approval-changes) (Let's Combinate)
- [219 - FDA PreCheck and the Future of Inspections: PAI to Pre-Readiness](https://hardwarepodcasts.com/podcast/lets-combinate/2025-12-24-219-fda-precheck-and-the-future-of-inspections-pai-to-pre-readiness) (Let's Combinate)
- [106 - FOIA, FDA Modernizing 510(k) Program, De Novo Submissions, and more databases with Michelle Lott](https://hardwarepodcasts.com/podcast/lets-combinate/2023-10-24-106-foia-fda-modernizing-510-k-program-de-novo-submissions-and-more-databases-wi) (Let's Combinate)
- [014A - "The First P: Product" with Larry Mager](https://hardwarepodcasts.com/podcast/lets-combinate/2022-01-05-014a-the-first-p-product-with-larry-mager) (Let's Combinate)

## Citing this page

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