Hardware Podcasts

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

Let's Combinate · 5 Apr 2023 · 35m

What this episode covers

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Requirements (EPRs) and international harmonization through IMDRF to address the gap between evolving technologies and outdated guidances.

Most relevant to

large enterprises

Topics

Mentioned

Companies
Becton Dickinson, FDA, CDRH
Products
auto injectors, smart connected devices
Also
IMDRF, EPRs

Related episodes from other shows

Other shows on the same ground, closest first.

  • 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 · 47m

    Regulatory Tips & Pointers from a Former FDA Reviewer

    Allison Komiyama, former FDA reviewer and owner of Acknowledge Regulatory Strategies, shares insights on the challenges facing the agency as veteran reviewers leave and new, remote staff struggle with mentorship. She explains how industry can improve review speeds by proactively supporting reviewers, such as by incorporating guidance documents into submissions and engaging in collaborative dialogue rather than relying solely on written correspondence. Komiyama also discusses the nuances of biocompatibility testing, noting that rigid checklists often lead to unnecessary animal testing and that reviewers should focus on risk-based interpretations of regulations.

    Certification & complianceSourcing & supply chain
    8 chapters

  • 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 · 38m

    #342: Planning an FDA Submission

    Ellie Reynolds, Associate Director of Quality Assurance and Regulatory Affairs at Proxima Clinical Research, explains the strategic planning required for FDA medical device submissions. She details the differences between 510(k), De Novo, and PMA pathways, emphasizing the critical role of Q-submissions (pre-submissions) and the eSTAR system in identifying documentation gaps early. Reynolds highlights the importance of realistic timeline management, including the 60-75 day wait for pre-sub meetings and potential review pauses, as well as navigating user fees and building collaborative relationships with FDA review teams.

    Certification & complianceValidation & product-market fit
    7 chapters

  • Global Medical Device Podcast · 41m

    What is a Multiple Function Device?

    Mike Drues from Vascular Sciences explains the regulatory framework for multiple function devices, defined as products containing both regulated medical device functions and non-regulated consumer functions. He analyzes FDA guidance using examples like smartphone skin cancer apps and handheld coagulation devices to show how non-device components are indirectly reviewed through risk mitigation. Drues advises manufacturers to decouple functions for individual risk assessment before evaluating the integrated system, and strongly recommends seeking pre-submission meetings with the FDA to align on strategy.

    Certification & complianceMedical & health devices
    7 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.