Hardware Podcasts

510(k) Tips and Answers to Frequently Asked Questions for Medical Device Companies

Global Medical Device Podcast · 6 May 2020 · 43m · Episode 145

What this episode covers

Mike Drues, president of Vascular Sciences, joins host Jon Speer to explain the 510(k) regulatory pathway for Class II medical devices, emphasizing the requirements for substantial equivalence and device classification. They discuss the three types of 510(k) submissions—Traditional, Special, and Abbreviated—and advise on timing, noting that design freeze and verification/validation testing must be complete before submission, with promissory notes being rarely accepted today. The conversation highlights the importance of clinical evidence based on the totality of evidence rather than pathway type, and details the Refuse to Accept (RTA) administrative review process, urging companies to use RTA checklists to avoid common paperwork errors.

Most relevant to

early-stage companies

Topics

Mentioned

Companies
Greenlight Guru, Vascular Sciences
Also
FDA, CDRH, EASTR

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and 513(g) classification processes, noting their timelines and costs, while advising companies to monitor draft guidance documents to anticipate FDA expectations during submissions.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 · 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 · 19m

    160 - Drug Tech Transfer vs. Device Design Transfer EXPLAINED!

    Host Subhi Saadeh explains the critical distinctions between drug tech transfer and device design transfer in combination products. He details how drug transfer relies on ICH Q10 for process validation and analytical method transfer, while device design transfer is governed by ISO 13485 and the Device History File (DHF). Saadeh highlights differences in regulatory submissions, such as CMC for drugs versus 510(k) or PMA for devices, and discusses the complexities of synchronizing timelines and supply chains for commercializing combination products.

    Design for manufacturing & NPICertification & compliance
    2 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

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.