# #467: Combination Product Compliance: PMOA, 21 CFR Part 4 & QMS Alignment

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2026-08-03
- Length: 35m
- Episode: 467
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-08-03-467-combination-product-compliance-pmoa-21-cfr-part-4-qms-alignment
- Listen: https://podcast.greenlight.guru/episode/combination-product-compliance-pmoa-21-cfr-part-4-qms-alignment

## Summary

Jim Fentress, Director of Regulatory Affairs at Galero (a Santa Group company), explains the regulatory complexities of combination products, focusing on how the Primary Mode of Action (PMOA) dictates FDA oversight. He details the challenges pharmaceutical companies face when integrating device Quality Management Systems (QMSR/ISO 13485) into their existing CGMP frameworks under 21 CFR Part 4. The discussion covers specific friction points like risk management alignment (AAMI TIR105 vs. ICH Q9), labeling classifications, and the critical need for transparent change control protocols between device manufacturers and pharma partners.

## Chapters

- [0:31](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-08-03-467-combination-product-compliance-pmoa-21-cfr-part-4-qms-alignment#t=31) Introduction to Combination Products and PMOA
- [1:46](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-08-03-467-combination-product-compliance-pmoa-21-cfr-part-4-qms-alignment#t=106) FDA Interagency Agreements and Lead Agency Designation
- [4:59](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-08-03-467-combination-product-compliance-pmoa-21-cfr-part-4-qms-alignment#t=299) 21 CFR Part 4 and QMS Integration Challenges
- [8:42](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-08-03-467-combination-product-compliance-pmoa-21-cfr-part-4-qms-alignment#t=522) Risk Management: AAMI TIR105 and ICH Q9 Alignment
- [12:11](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-08-03-467-combination-product-compliance-pmoa-21-cfr-part-4-qms-alignment#t=731) Design Controls and Human Factors Validation
- [14:36](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-08-03-467-combination-product-compliance-pmoa-21-cfr-part-4-qms-alignment#t=876) Labeling Pathways: Single Entity, Co-Packaged, and Cross-Labeled
- [18:02](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-08-03-467-combination-product-compliance-pmoa-21-cfr-part-4-qms-alignment#t=1082) Change Control Risks and Pharma-Device Communication
- [20:21](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-08-03-467-combination-product-compliance-pmoa-21-cfr-part-4-qms-alignment#t=1221) Advice for Device Manufacturers Partnering with Pharma

## Topics

- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Design for manufacturing & NPI](https://hardwarepodcasts.com/topic/design-for-manufacturing)
- [Manufacturing partners & offshoring](https://hardwarepodcasts.com/topic/manufacturing-partners)

## Most relevant to

established companies

## Mentioned

- Galero (company)
- Santa Group (company)
- FDA (company)
- CDRH (company)
- CDER (company)
- EMA (company)
- AAMI TIR105 (other)
- ISO 14971 (other)
- ICH Q9 (other)
- ISO 13485 (other)
- 21 CFR Part 4 (other)
- 21 CFR Part 210 (other)
- 21 CFR Part 211 (other)
- Greenlight Guru (company)

## Related episodes from other shows

- [092 - Putting it all together: Drug cGMP’s 210/211/ICH and Device QMS 820/ISO13485 with Aaron Snyder](https://hardwarepodcasts.com/podcast/lets-combinate/2023-07-05-092-putting-it-all-together-drug-cgmps-210-211-ich-and-device-qms-820-iso13485-w) (Let's Combinate)
- [125 - Unpacking the Quality Management System Regulation(QMSR) Final Rule with Subhi Saadeh](https://hardwarepodcasts.com/podcast/lets-combinate/2024-02-28-125-unpacking-the-quality-management-system-regulation-qmsr-final-rule-with-subh) (Let's Combinate)
- [257 - 21 CFR Part 4 Explained: CGMP Requirements for Combination Products](https://hardwarepodcasts.com/podcast/lets-combinate/2026-10-05-257-21-cfr-part-4-explained-cgmp-requirements-for-combination-products) (Let's Combinate)
- [155 - FDA Compliance Programs, Program 7536.000: CDER vs. CDRH led Inspections, Mock PAI's, Supplier Management, and What is a Manufacturer? with Laurie Auerbach](https://hardwarepodcasts.com/podcast/lets-combinate/2024-09-25-155-fda-compliance-programs-program-7536-000-cder-vs-cdrh-led-inspections-mock-p) (Let's Combinate)
- [217 - 5 Fixable Problems Holding Back Drug–Device Programs](https://hardwarepodcasts.com/podcast/lets-combinate/2025-12-10-217-5-fixable-problems-holding-back-drug-device-programs) (Let's Combinate)

## Citing this page

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