Hardware Podcasts

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

Let's Combinate · 10 Jan 2024 · 37m

What this episode covers

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.

Most relevant to

established companies

Topics

Mentioned

Companies
CP Pathways
Products
MediPad
Also
CDER, CDRH, FDA, EMA

Related episodes from other shows

Other shows on the same ground, closest first.

  • Global Medical Device Podcast · 38m

    #380: Navigating the Complex World of Combination Products with Subhi Saadeh

    Subhi Saadeh, host of the Combinate Podcast and expert in combination products, discusses the regulatory complexities of integrating drugs, devices, and biologics, including the differences between US FDA and EU regulatory pathways. He explains the definitions of single entity, co-packaged, and cross-labeled products, and addresses common misconceptions about the differences between drug and device quality systems. Saadeh also shares his journey of starting the podcast to maintain consistent learning and production, highlighting the importance of lifelong learning and leveraging coaching to balance technical and business aspects of the MedTech industry.

    Medical & health devicesCertification & compliance
    8 chapters

  • Global Medical Device Podcast · 27m

    DHF vs. DMR vs. DHR: Understanding the Differences & How They Interact

    Laura Court, a Medical Device Guru at Greenlight Guru, explains the distinct roles and interactions of the Design History File (DHF), Device Master Record (DMR), and Device History Record (DHR) in medical device development. She emphasizes that the DHF is the history of product development, the DMR is the manufacturing recipe, and the DHR is the batch-specific production record. Court advises engineers to start documenting early, use multiple design reviews to catch stakeholder input, and leverage tribal knowledge from manufacturing teams to improve processes.

    Medical & health devicesQuality & yield
    7 chapters

  • Global Medical Device Podcast · 42m

    #323 The Combination Products Handbook

    Susan Neadle, principal consultant and president of Combination Products Consulting Services, discusses her peer-reviewed book, The Combination Products Handbook: A Practical Guide, published by CRC Press. Neadle explains how she collaborated with FDA officials, including John Barwiener, and industry experts from companies like Johnson & Johnson, Novartis, and Pfizer to create a consolidated resource for the complex niche of combination products. The episode details the book's structure, covering regulatory strategies, CGMPs, risk management, and human factors, while highlighting the challenges of harmonizing terminology between pharmaceutical and medical device sectors. Neadle emphasizes the importance of holistic thinking and integrated development to ensure patient safety and regulatory compliance across global jurisdictions.

    Medical & health devicesCertification & compliance
    9 chapters

  • Global Medical Device Podcast · 35m

    #467: Combination Product Compliance: PMOA, 21 CFR Part 4 & QMS Alignment

    Jim Fentress, Director of Regulatory Affairs at Galero (a Santa Group company), explains the regulatory complexities of combination products, focusing on how the Primary Mode of Action (PMOA) dictates FDA oversight. He details the challenges pharmaceutical companies face when integrating device Quality Management Systems (QMSR/ISO 13485) into their existing CGMP frameworks under 21 CFR Part 4. The discussion covers specific friction points like risk management alignment (AAMI TIR105 vs. ICH Q9), labeling classifications, and the critical need for transparent change control protocols between device manufacturers and pharma partners.

    Certification & complianceDesign for manufacturing & NPI
    8 chapters

  • Global Medical Device Podcast · 38m

    How to Choose the Right FDA Regulatory Pathway for your Device

    Mike Drues of Vascular Sciences joins host John Spear to explain that medical device companies have 7 major FDA regulatory pathways, including 510(k), PMA, De Novo, HDE, PDP, CDE, and EAP, rather than just the two commonly known options. Drues details how classification depends on both technology and labeling, allowing companies to 'wordsmith' claims to access different routes, such as using a Humanitarian Device Exemption (HDE) for narrow patient populations or a Custom Device Exemption (CDE) for personalized 3D-printed devices. The discussion highlights strategic combinations, such as using an Emergency Access Program (EAP) for early feasibility data before a full PMA, or pursuing anatomy-specific pathways for the same device. Drues also clarifies that programs like Breakthrough Devices Program (BDP) and Safer Technologies Program (STEP) are not standalone pathways but efficiency accelerators for standard submissions.

    Certification & compliance
    8 chapters

The summary, chapters and topics are generated from the episode’s audio by this directory, not written by Let's Combinate. The episode itself belongs to its publisher.