# 139 - FDA Platform Guidance, EMA Q&A Guidance for Drug Device Combinations, USP and Sugar Badger 50k Race Recap with Subhi Saadeh

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2024-06-05
- Length: 27m
- Page: https://hardwarepodcasts.com/podcast/lets-combinate/2024-06-05-139-fda-platform-guidance-ema-q-a-guidance-for-drug-device-combinations-usp-and
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/139---FDA-Platform-Guidance--EMA-QA-Guidance-for-Drug-Device-Combinations--USP-and-Sugar-Badger-50k-Race-Recap-with-Subhi-Saadeh-e2kgk63

## Summary

Subhi Saadeh, host of the Let's Combinate podcast and Quality Professional, reviews three recent regulatory updates for drug-device combination products: the FDA's draft guidance on Platform Technology Designation, the EMA's Q&A on EU MDR implementation, and a new USP informational chapter on device monographs. Saadeh analyzes how the FDA's exclusion of device delivery systems from platform designation might hinder efficiency, while noting the EMA's focus on notified body opinions and post-approval changes. He concludes with a personal recap of completing the Sugar Badger 50K race, discussing his training, race strategy, and physical challenges.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/lets-combinate/2024-06-05-139-fda-platform-guidance-ema-q-a-guidance-for-drug-device-combinations-usp-and#t=0) Introduction and Episode Overview

## Topics

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

## Most relevant to

established companies

## Mentioned

- FDA (company)
- EMA (company)
- USP (company)
- EU MDR (other)
- Sugar Badger 50K (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)
- [#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)
- [#343: Recent FDA Draft Guidances](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-11-09-343-recent-fda-draft-guidances) (Global Medical Device Podcast)
- [The Best of Jon & Mike Through the Years](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-12-29-the-best-of-jon-mike-through-the-years) (Global Medical Device Podcast)
- [Focusing on the Intent of the UDI Requirements from FDA's Final Guidance Doc](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-09-16-focusing-on-the-intent-of-the-udi-requirements-from-fdas-final-guidance-doc) (Global Medical Device Podcast)

## Citing this page

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