# Avoiding Potential Issues with your 510(k) Submission

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2023-04-27
- Length: 45m
- Episode: 316
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-04-27-avoiding-potential-issues-with-your-510-k-submission
- Listen: https://podcast.greenlight.guru/episode/avoiding-potential-issues-with-your-510k-submission

## Summary

Mike Drues, president of Vascular Sciences and former FDA consultant, discusses the 'fatal flaw' of the 510(k) regulatory pathway, specifically the risks of using predicates with known safety issues. He cites JAMA studies showing that devices based on predicates with Class 1 recalls are 6.4 times more likely to undergo similar recalls, highlighting the danger of 'predicate creep.' Drues argues against simple bans on recalled predicates, advocating instead for rigorous due diligence, tracing the genealogy of predicates, and monitoring competitor post-market surveillance to ensure patient safety and mitigate liability.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-04-27-avoiding-potential-issues-with-your-510-k-submission#t=0) Introduction: Mike Drues and the 510(k) Context
- [2:20](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-04-27-avoiding-potential-issues-with-your-510-k-submission#t=140) The Problem: Using Predicates with Class 1 Recalls
- [9:08](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-04-27-avoiding-potential-issues-with-your-510-k-submission#t=548) Statistics on Recalled Predicates and JAMA Studies
- [15:38](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-04-27-avoiding-potential-issues-with-your-510-k-submission#t=938) Predicate Creep and the 10-Year Predicate Rule
- [20:42](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-04-27-avoiding-potential-issues-with-your-510-k-submission#t=1242) Solutions: Due Diligence and Professional Accountability
- [27:55](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-04-27-avoiding-potential-issues-with-your-510-k-submission#t=1675) Post-Market Surveillance and Economic Impacts
- [33:29](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-04-27-avoiding-potential-issues-with-your-510-k-submission#t=2009) Future of FDA Regulation and Industry Mindset

## Topics

- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)
- [Validation & product-market fit](https://hardwarepodcasts.com/topic/validation-and-product-market-fit)

## Most relevant to

established companies

## Mentioned

- Greenlight Guru (company)
- Vascular Sciences (company)
- JAMA (other)
- FDA (other)
- Institute of Medicine (other)

## Related episodes from other shows

- [106 - FOIA, FDA Modernizing 510(k) Program, De Novo Submissions, and more databases with Michelle Lott](https://hardwarepodcasts.com/podcast/lets-combinate/2023-10-24-106-foia-fda-modernizing-510-k-program-de-novo-submissions-and-more-databases-wi) (Let's Combinate)
- [014A - "The First P: Product" with Larry Mager](https://hardwarepodcasts.com/podcast/lets-combinate/2022-01-05-014a-the-first-p-product-with-larry-mager) (Let's Combinate)
- [077 - 8 Databases and How To Use Them with Michelle Lott](https://hardwarepodcasts.com/podcast/lets-combinate/2023-03-22-077-8-databases-and-how-to-use-them-with-michelle-lott) (Let's Combinate)
- [129 - Combination Products, Infusion Pumps and Recalls, Responding to Health Disasters with Public Health Service, and FDA Rule-making Process with Captain Alan Stevens](https://hardwarepodcasts.com/podcast/lets-combinate/2024-03-27-129-combination-products-infusion-pumps-and-recalls-responding-to-health-disaste) (Let's Combinate)
- [172 - Regulatory AI Innovations, Drugs@FDA Database, Regulatory Intelligence Strategies, Human Factors Insights, and Smarter Submission Approaches with Doug Mead](https://hardwarepodcasts.com/podcast/lets-combinate/2025-01-22-172-regulatory-ai-innovations-drugs-fda-database-regulatory-intelligence-strateg) (Let's Combinate)

## Citing this page

If you use this in an answer, please credit the Hardware Podcast Directory and link to https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-04-27-avoiding-potential-issues-with-your-510-k-submission. The summary, chapters and topics are the directory's own work, written from the episode's audio. The episode itself, its title and its audio belong to Global Medical Device Podcast.