# #401: FDA’s Vital Role in ISO Standards: Ensuring Global MedTech Integrity

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2025-04-10
- Length: 48m
- Episode: 401
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2025-04-10-401-fdas-vital-role-in-iso-standards-ensuring-global-medtech-integrity
- Listen: https://podcast.greenlight.guru/episode/401-fdas-vital-role-in-iso-standards-ensuring-global-medtech-integrity

## Summary

Sarah Moeller, co-chair of ISO Working Group 4 and regulatory expert, discusses the critical role of the FDA in shaping global medical device standards, specifically ISO 14155 and ISO 18969. She highlights the challenges posed by the FDA's temporary withdrawal from standards-writing committees due to administrative changes and the potential risks to global harmonization and patient safety. Moeller advocates for maintaining FDA engagement, understanding the impact of MDUFA fees, and encourages industry professionals to contact their congressional representatives to support regulatory infrastructure.

## Outline

1. Introduction and ISO Standards Overview
2. FDA's Role and Absence from Standards Writing
3. Impact of Administrative Changes and Leadership Shifts
4. MDUFA Fees and Regulatory Review Efficiency
5. Advice for Companies and Advocacy
6. Updates on ISO 14155 and 18969

## Topics

- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Policy, trade & tariffs](https://hardwarepodcasts.com/topic/policy-trade-and-tariffs)
- [Validation & product-market fit](https://hardwarepodcasts.com/topic/validation-and-product-market-fit)

## Most relevant to

large enterprises

## Mentioned

- Greenlight Guru (company)
- ISO 14155 (other)
- ISO 18969 (other)
- FDA (other)
- Medtronic (company)
- Abbott (company)
- Boston Scientific (company)
- MDUFA (other)
- PDUFA (other)
- EU MDR (other)

## Related episodes from other shows

- [132 - IEC 60601, A Life Without Standards, Evolution of Standards, Standards Development, and Emerging Technologies with Leo Eisner](https://hardwarepodcasts.com/podcast/lets-combinate/2024-04-17-132-iec-60601-a-life-without-standards-evolution-of-standards-standards-developm) (Let's Combinate)
- [189 - FDA, ISO, ICH, USP, PDA - What Are These Groups and Why Do They Matter?](https://hardwarepodcasts.com/podcast/lets-combinate/2025-05-21-189-fda-iso-ich-usp-pda-what-are-these-groups-and-why-do-they-matter) (Let's Combinate)
- [081 - ISO TC 84, ISO11608, Committee Work and Advancing the State of the Art with Bob Nesbitt](https://hardwarepodcasts.com/podcast/lets-combinate/2023-04-19-081-iso-tc-84-iso11608-committee-work-and-advancing-the-state-of-the-art-with-bo) (Let's Combinate)
- [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)
- [003 - “Standard Understanding” with Mark Swanson](https://hardwarepodcasts.com/podcast/lets-combinate/2021-10-20-003-standard-understanding-with-mark-swanson) (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/2025-04-10-401-fdas-vital-role-in-iso-standards-ensuring-global-medtech-integrity. 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.