# 079 - How FDA Reviews Combination Products, Policy, EPR's, and Harmonization with Rumi Young

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2023-04-05
- Length: 35m
- Page: https://hardwarepodcasts.com/podcast/lets-combinate/2023-04-05-079-how-fda-reviews-combination-products-policy-eprs-and-harmonization-with-rumi
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/079---How-FDA-Reviews-Combination-Products--Policy--EPRs--and-Harmonization-with-Rumi-Young-e21ev16

## Summary

Rumi Young, Director of Regulatory Policy at Becton Dickinson (BD), explains how the FDA reviews combination products, drawing on her previous tenure as Acting Assistant Director in CDRH’s Division of Drug Delivery. She details the inter-center consult process for products like auto-injectors and smart connected devices, highlighting the manual nature of current submissions and the critical need for clear device identification in NDAs and BLAs. Young discusses the role of industry in shaping policy, advocating for updated Essential Performance Requirements (EPRs) and international harmonization through IMDRF to address the gap between evolving technologies and outdated guidances.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/lets-combinate/2023-04-05-079-how-fda-reviews-combination-products-policy-eprs-and-harmonization-with-rumi#t=0) Introduction: Rumi Young and BD
- [2:12](https://hardwarepodcasts.com/podcast/lets-combinate/2023-04-05-079-how-fda-reviews-combination-products-policy-eprs-and-harmonization-with-rumi#t=132) Rumi Young's Career: From Pharma to FDA
- [4:35](https://hardwarepodcasts.com/podcast/lets-combinate/2023-04-05-079-how-fda-reviews-combination-products-policy-eprs-and-harmonization-with-rumi#t=275) Creating Technical and Regulatory Policy at FDA
- [6:14](https://hardwarepodcasts.com/podcast/lets-combinate/2023-04-05-079-how-fda-reviews-combination-products-policy-eprs-and-harmonization-with-rumi#t=374) The Inter-Center Consult Process for Combination Products
- [12:56](https://hardwarepodcasts.com/podcast/lets-combinate/2023-04-05-079-how-fda-reviews-combination-products-policy-eprs-and-harmonization-with-rumi#t=776) Industry's Role in Shaping Regulatory Policy
- [23:09](https://hardwarepodcasts.com/podcast/lets-combinate/2023-04-05-079-how-fda-reviews-combination-products-policy-eprs-and-harmonization-with-rumi#t=1389) Reviewing Connected Devices and Clinical Risk-Benefit
- [26:36](https://hardwarepodcasts.com/podcast/lets-combinate/2023-04-05-079-how-fda-reviews-combination-products-policy-eprs-and-harmonization-with-rumi#t=1596) The Push for Essential Performance Requirements (EPRs)
- [31:47](https://hardwarepodcasts.com/podcast/lets-combinate/2023-04-05-079-how-fda-reviews-combination-products-policy-eprs-and-harmonization-with-rumi#t=1907) International Harmonization and IMDRF

## Topics

- [Connected products & IoT](https://hardwarepodcasts.com/topic/connected-products-and-iot)
- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Policy, trade & tariffs](https://hardwarepodcasts.com/topic/policy-trade-and-tariffs)
- [Medical & health devices](https://hardwarepodcasts.com/topic/medical-devices)
- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)

## Most relevant to

large enterprises

## Mentioned

- Becton Dickinson (company)
- FDA (company)
- CDRH (company)
- IMDRF (other)
- auto injectors (product)
- smart connected devices (product)
- EPRs (other)

## Related episodes from other shows

- [#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)
- [Regulatory Tips & Pointers from a Former FDA Reviewer](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-05-17-regulatory-tips-pointers-from-a-former-fda-reviewer) (Global Medical Device Podcast)
- [#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)
- [#342: Planning an FDA Submission](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-11-02-342-planning-an-fda-submission) (Global Medical Device Podcast)
- [What is a Multiple Function Device?](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-09-30-what-is-a-multiple-function-device) (Global Medical Device Podcast)

## Citing this page

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