Hardware Podcasts

When to Throw the Least Burdensome Flag on FDA

Global Medical Device Podcast · 6 Oct 2021 · 34m · Episode 230

What this episode covers

Mike Drues, President of Vascular Sciences, explains how medical device manufacturers can respond to overly burdensome Additional Information Requests (AIR) from the FDA using the 'Least Burdensome Flag' pilot program. He outlines a hierarchy of responses, starting with informal negotiations with reviewers to reach a compromise, escalating to division management, and formally invoking the flag if necessary. Drues emphasizes that companies must justify testing requests based on biology and engineering rather than blindly complying, warning that the 'nuclear option' of involving the Ombudsman can damage long-term relationships with the agency.

Most relevant to

early-stage companies

Topics

Mentioned

Companies
Vascular Sciences, Greenlight Guru
Also
FDA, CDRH, 510(k), IDE, ISO 10993

Related episodes from other shows

Other shows on the same ground, closest first.

  • 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 · 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and 513(g) classification processes, noting their timelines and costs, while advising companies to monitor draft guidance documents to anticipate FDA expectations during submissions.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 · 1h 16m

    012 - "Asking then Seeing" with Sara Waxberg Mcnew

    Sara Waxberg McNew, Chief Scientific Officer at Design Science, explains the human factors process for medical devices, emphasizing the distinction between formative studies and summative validation. She details how to interpret ANSI/AAMI HE75 and IEC 62366-1 standards, manage risk for combination products, and handle regulatory submissions with the FDA. The discussion covers specific challenges like testing rare patient populations, using surrogates, and conducting threshold analyses for generics.

    Medical & health devicesValidation & product-market fit
    12 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.