# 171 - Are Pre-Filled Syringes with Vaccines, Biologics, Generics, or Small Molecules considered Combination Products?

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2025-01-13
- Length: 7m
- Page: https://hardwarepodcasts.com/podcast/lets-combinate/2025-01-13-171-are-pre-filled-syringes-with-vaccines-biologics-generics-or-small-molecules
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/171---Are-Pre-Filled-Syringes-with-Vaccines--Biologics--Generics--or-Small-Molecules-considered-Combination-Products-e2tf7jl

## Summary

Subhi Saadeh, host of Let's Combinate and Quality Professional, explains why pre-filled syringes (PFS) are classified as combination products and how regulatory requirements vary by region. He details the US FDA's Primary Mode of Action (PMOA) framework, the EU's MDR Article 117 requirements, and the drug-led approaches in China and Japan. Saadeh uses a case study of filling water for reconstitution to illustrate the technical and regulatory hurdles, emphasizing that understanding jurisdiction-specific definitions is critical for product design and approval timelines.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/lets-combinate/2025-01-13-171-are-pre-filled-syringes-with-vaccines-biologics-generics-or-small-molecules#t=0) Introduction: Subhi Saadeh and the PFS Challenge

## Topics

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

## Most relevant to

early-stage companies

## Mentioned

- FDA (other)
- CDER (other)
- CBER (other)
- MDR (other)
- GSPR (other)
- EMA (other)
- ASTM Committee E55 (other)
- Combination Products Coalition (other)

## 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)
- [#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)
- [Developing a Regulatory Strategy](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-11-23-developing-a-regulatory-strategy) (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)
- [Preparing Your Pre-Submission with the Content FDA Wants to See](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-06-23-preparing-your-pre-submission-with-the-content-fda-wants-to-see) (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/2025-01-13-171-are-pre-filled-syringes-with-vaccines-biologics-generics-or-small-molecules. 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.