# 211 - Inside FDA’s Office of Combination Products: History, PMOA, and What’s Next for Combination Products with Mark Kramer

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2025-10-30
- Length: 46m
- Page: https://hardwarepodcasts.com/podcast/lets-combinate/2025-10-30-211-inside-fdas-office-of-combination-products-history-pmoa-and-whats-next-for-c
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/211---Inside-FDAs-Office-of-Combination-Products-History--PMOA--and-Whats-Next-for-Combination-Products-with-Mark-Kramer-e39s23c

## Summary

Mark Kramer, founding director of the FDA’s Office of Combination Products (OCP) and now Principal at Eliquent Life Sciences, explains the history and regulatory framework for combination products in the U.S. He details how the 1990 Safe Medical Devices Act and the 2002 Medical Device User Fee and Modernization Act (MDUFA) led to the creation of OCP, driven initially by the device industry's need to regulate drug-eluting coronary stents. Kramer discusses the Primary Mode of Action (PMOA) rule, the shift from device-led to pharma-led combination products, and current regulatory gaps such as cross-labeling and site registration ambiguities.

## Chapters

- [0:06](https://hardwarepodcasts.com/podcast/lets-combinate/2025-10-30-211-inside-fdas-office-of-combination-products-history-pmoa-and-whats-next-for-c#t=6) Introduction & Historical Background
- [1:29](https://hardwarepodcasts.com/podcast/lets-combinate/2025-10-30-211-inside-fdas-office-of-combination-products-history-pmoa-and-whats-next-for-c#t=89) Creation of OCP & MDUFA
- [14:08](https://hardwarepodcasts.com/podcast/lets-combinate/2025-10-30-211-inside-fdas-office-of-combination-products-history-pmoa-and-whats-next-for-c#t=848) Defining Primary Mode of Action (PMOA)
- [18:26](https://hardwarepodcasts.com/podcast/lets-combinate/2025-10-30-211-inside-fdas-office-of-combination-products-history-pmoa-and-whats-next-for-c#t=1106) OCP’s Role & Responsibilities
- [26:43](https://hardwarepodcasts.com/podcast/lets-combinate/2025-10-30-211-inside-fdas-office-of-combination-products-history-pmoa-and-whats-next-for-c#t=1603) Industry Adoption & Pharma Shift
- [38:08](https://hardwarepodcasts.com/podcast/lets-combinate/2025-10-30-211-inside-fdas-office-of-combination-products-history-pmoa-and-whats-next-for-c#t=2288) Regulatory Gaps & Future Directions

## Topics

- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Medical & health devices](https://hardwarepodcasts.com/topic/medical-devices)
- [Policy, trade & tariffs](https://hardwarepodcasts.com/topic/policy-trade-and-tariffs)

## Most relevant to

large enterprises

## Mentioned

- FDA (company)
- Office of Combination Products (other)
- Eliquent Life Sciences (company)
- Greenleaf Health (company)
- Safe Medical Devices Act (other)
- MDUFA (other)
- PDUFA (other)
- 21 CFR 3.4 (other)
- Part 4 (other)

## Related episodes from other shows

- [#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)
- [#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)
- [#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)
- [A Regulatory Gap Analysis of FDA's Systems & Policies](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-01-26-a-regulatory-gap-analysis-of-fdas-systems-policies) (Global Medical Device Podcast)
- [How to Choose the Right FDA Regulatory Pathway for your Device](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-02-26-how-to-choose-the-right-fda-regulatory-pathway-for-your-device) (Global Medical Device Podcast)

## Citing this page

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