# 118 - What are Drug/Device Master Files and When to Use for Combination Product Submissions? with Doug Mead

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2024-01-10
- Length: 37m
- Page: https://hardwarepodcasts.com/podcast/lets-combinate/2024-01-10-118-what-are-drug-device-master-files-and-when-to-use-for-combination-product-su
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/118---What-are-DrugDevice-Master-Files-and-When-to-Use-for-Combination-Product-Submissions--with-Doug-Mead-e2e4lkm

## Summary

Doug Mead, founder of CP Pathways, explains the regulatory differences between Drug Master Files (DMFs) and Device Master Files (MAFs) for combination products. He details the five types of DMFs and contrasts them with the less formal MAFs, noting that CDRH and CDER often lack cross-access to each other's files. Mead argues that for finished devices or platforms, it is often more efficient to include device content directly in Module 3.2.R of an NDA or BLA rather than maintaining a separate MAF. He highlights challenges such as supplier reluctance to grant Letters of Authorization and the redundancy of updating both a master file and a supplement.

## Chapters

- [1:46](https://hardwarepodcasts.com/podcast/lets-combinate/2024-01-10-118-what-are-drug-device-master-files-and-when-to-use-for-combination-product-su#t=106) Introduction to DMF and MAF Types
- [5:10](https://hardwarepodcasts.com/podcast/lets-combinate/2024-01-10-118-what-are-drug-device-master-files-and-when-to-use-for-combination-product-su#t=310) Doug Mead's Experience with Early Master Files
- [5:15](https://hardwarepodcasts.com/podcast/lets-combinate/2024-01-10-118-what-are-drug-device-master-files-and-when-to-use-for-combination-product-su#t=315) Challenges and Redundancy of MAFs
- [8:52](https://hardwarepodcasts.com/podcast/lets-combinate/2024-01-10-118-what-are-drug-device-master-files-and-when-to-use-for-combination-product-su#t=532) The Role and Limitations of Device Master Files
- [8:52](https://hardwarepodcasts.com/podcast/lets-combinate/2024-01-10-118-what-are-drug-device-master-files-and-when-to-use-for-combination-product-su#t=532) Overlap and Access Issues Between CDER and CDRH
- [17:25](https://hardwarepodcasts.com/podcast/lets-combinate/2024-01-10-118-what-are-drug-device-master-files-and-when-to-use-for-combination-product-su#t=1045) Advocating for Module 3.2.R Over MAFs
- [23:58](https://hardwarepodcasts.com/podcast/lets-combinate/2024-01-10-118-what-are-drug-device-master-files-and-when-to-use-for-combination-product-su#t=1438) The Device Roadmap and Reviewer Guidance
- [31:14](https://hardwarepodcasts.com/podcast/lets-combinate/2024-01-10-118-what-are-drug-device-master-files-and-when-to-use-for-combination-product-su#t=1874) Future Trends and Supplier Relationships

## Topics

- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Medical & health devices](https://hardwarepodcasts.com/topic/medical-devices)
- [Sourcing & supply chain](https://hardwarepodcasts.com/topic/sourcing-and-supply-chain)

## Most relevant to

established companies

## Mentioned

- CP Pathways (company)
- CDER (other)
- CDRH (other)
- MediPad (product)
- FDA (other)
- EMA (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)
- [DHF vs. DMR vs. DHR: Understanding the Differences & How They Interact](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-03-02-dhf-vs-dmr-vs-dhr-understanding-the-differences-how-they-interact) (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)
- [#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)
- [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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