Hardware Podcasts

#342: Planning an FDA Submission

Global Medical Device Podcast · 2 Nov 2023 · 38m · Episode 342

What this episode covers

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.

Most relevant to

early-stage companies

Topics

Mentioned

Companies
Proxima Clinical Research, Greenlight Guru
Tools
eSTAR
Also
FDA

Related episodes from other shows

Other shows on the same ground, closest first.

  • Let's Combinate · 33m

    106 - FOIA, FDA Modernizing 510(k) Program, De Novo Submissions, and more databases with Michelle Lott

    Michelle Lott, founder of leanRAQA, explains how to navigate eight FDA databases, including using FOIA requests to access redacted 510(k) summaries and reviewing 483 and Warning Letter databases to identify regulatory trends. She details the recent modernization of the 510(k) program, specifically new guidance on predicate selection and clinical data, and contrasts the 510(k) pathway with the De Novo process for novel devices. Lott also outlines the Pre-Submission and 513(g) classification processes, noting their timelines and costs, while advising companies to monitor draft guidance documents to anticipate FDA expectations during submissions.

    Certification & complianceSourcing & supply chain
    8 chapters

  • Let's Combinate · 1h 19m

    031 - "The Five Stages Of Regulatory Grief" with Michelle Lott

    Michelle Lott, founder of Lean RAQA, discusses her journey from large manufacturer Baxter Healthcare to consulting for small-to-mid-size medical device companies, highlighting the gap in practical regulatory strategy. She details the 'five stages of regulatory grief' clients experience when facing FDA interactions, contrasting the US 510(k) process with the rigorous, ongoing costs of EU MDR compliance. Lott also explains the nuances of regulations versus guidance documents, the QMSR harmonization, and her unique perspective as an elected industry representative on the FDA Device GMP Advisory Committee.

    Certification & complianceQuality & yield
    11 chapters

  • Let's Combinate · 35m

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

    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.

    Connected products & IoTCertification & compliance
    8 chapters

  • Let's Combinate · 28m

    074 - Article 117, EU MDR extension, Notified Body Opinions, Timing and Interaction with Christiana Hoffman

    Christiana Hoffman, Executive Consultant at anteris medical GmbH and former TÜV SÜD expert, explains the regulatory framework for drug-device combination products under EU MDR Article 117. She details the requirement for Notified Body Opinions for products like prefilled syringes, the distinction between GMP and ISO 13485, and the strict prohibition on consulting during the assessment process. Hoffman also outlines the timeline challenges, noting that assessments can take 75 days plus response time, and advises manufacturers to start the process 6-12 months before their EMA submission.

    Certification & complianceQuality & yield
    8 chapters

  • Let's Combinate · 22m

    077 - 8 Databases and How To Use Them with Michelle Lott

    Michelle Lott, founder of leanRAQA, walks through eight critical FDA databases for medical device regulatory strategy, including the Product Classification Database, 510(k) Database, and Registration and Listing Database. She explains how to use these tools to determine submission types, identify competitors, and access redacted technical data via FOIA requests. Lott also highlights the importance of the Guidance Document Database and the Code of Federal Regulations (CFR) for understanding specific regulatory requirements and consensus standards.

    Certification & compliance
    8 chapters

The summary, chapters and topics are generated from the episode’s audio by this directory, not written by Global Medical Device Podcast. The episode itself belongs to its publisher.