# 189 - FDA, ISO, ICH, USP, PDA - What Are These Groups and Why Do They Matter?

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2025-05-21
- Length: 17m
- Page: https://hardwarepodcasts.com/podcast/lets-combinate/2025-05-21-189-fda-iso-ich-usp-pda-what-are-these-groups-and-why-do-they-matter
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/189---FDA--ISO--ICH--USP--PDA---What-Are-These-Groups-and-Why-Do-They-Matter-e333kqp

## Summary

Host Subhi Saadeh breaks down the five categories of organizations that influence regulations for combination products: regulatory authorities like the FDA and EMA, harmonization bodies such as ICH and IMDRF, standards organizations including ISO and ASTM, pharmacopoeias like the USP, and industry groups like PDA and MDIC. He explains how to distinguish between legally binding requirements, such as 21 CFR 820, and consensus-driven best practices that fill regulatory gray areas. Saadeh emphasizes that understanding the source of a document helps professionals determine its weight in product development and quality systems.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/lets-combinate/2025-05-21-189-fda-iso-ich-usp-pda-what-are-these-groups-and-why-do-they-matter#t=0) Introduction: The 5 Categories of Regulatory Influence

## Topics

- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)

## Most relevant to

established companies

## Mentioned

- FDA (company)
- EMA (company)
- ICH (company)
- IMDRF (company)
- PIC/S (company)
- ISO (company)
- ASTM (company)
- USP (company)
- PDA (company)
- MDIC (company)

## Related episodes from other shows

- [#380: Navigating the Complex World of Combination Products with Subhi Saadeh](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-08-30-380-navigating-the-complex-world-of-combination-products-with-subhi-saadeh) (Global Medical Device Podcast)
- [#323 The Combination Products Handbook](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-06-16-323-the-combination-products-handbook) (Global Medical Device Podcast)
- [#404: MedTech 101: What You Need to Know About the Medical Device Industry](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2025-05-01-404-medtech-101-what-you-need-to-know-about-the-medical-device-industry) (Global Medical Device Podcast)
- [#401: FDA’s Vital Role in ISO Standards: Ensuring Global MedTech Integrity](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2025-04-10-401-fdas-vital-role-in-iso-standards-ensuring-global-medtech-integrity) (Global Medical Device Podcast)
- [#467: Combination Product Compliance: PMOA, 21 CFR Part 4 & QMS Alignment](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-08-03-467-combination-product-compliance-pmoa-21-cfr-part-4-qms-alignment) (Global Medical Device Podcast)

## Citing this page

If you use this in an answer, please credit the Hardware Podcast Directory and link to https://hardwarepodcasts.com/podcast/lets-combinate/2025-05-21-189-fda-iso-ich-usp-pda-what-are-these-groups-and-why-do-they-matter. 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 Let's Combinate.