Hardware Podcasts

#346: FDAs eSTAR Program

Global Medical Device Podcast · 30 Nov 2023 · 47m · Episode 346

What this episode covers

Patrick Axtell from the FDA, along with Lisa Pritchard and Kathy Herzog from DuVal & Associates, discuss the mandatory eSTAR program for 510(k) submissions. They explain how the standardized template automates data collection, integrates guidance documents, and eliminates the Refuse to Accept (RTA) checklist to streamline reviews. The experts share strategies for building advocacy through the executive summary and managing attachments offline to avoid common pitfalls like missing content or formatting errors.

Most relevant to

large enterprises

Topics

Mentioned

Companies
FDA, DuVal & Associates, Greenlight Guru, Health Canada
Tools
eSTAR
Also
510(k), De Novo, PMA

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and 513(g) classification processes, noting their timelines and costs, while advising companies to monitor draft guidance documents to anticipate FDA expectations during submissions.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 · 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

  • 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 · 9m

    256 - The New FDA Inspection Playbook: Where to Start with QMSR

    Subhi Saadeh, founder of Let’s Combinate, introduces a four-part series on FDA inspection readiness under the new Quality Management System Regulation (QMSR), explaining how the retired QSIT framework has been replaced by Compliance Program 7382.850. He highlights advice from former FDA investigator Eric Pittman, who advises industry to focus exclusively on Section III of compliance programs as the primary roadmap for inspections. The episode details the shift from QSIT’s four major subsystems to six QMS areas, emphasizing a risk-based approach where investigators evaluate product risks and control effectiveness.

    Certification & compliance
    3 chapters

  • People of Packaging · 27m

    242 - LIVE from Austin, TX with Casey Nakamura

    Casey Nakamura, a packaging professional at Johnson & Johnson Vision, discusses building a dedicated packaging engineering group and implementing Specright to centralize specification data for medical device packaging. He explains how moving from fragmented responsibilities to a structured database of 7 engineers improves sustainability reporting and operational efficiency. Nakamura also highlights the industry-wide pain point of manual data tracking and vendor data hoarding, arguing that digital specification management is critical for compliance with regulations like California's EPR bill and for enabling faster innovation.

    Connected products & IoTSustainability & circular products
    6 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.