# 7 Common 510(k) Mistakes and How to Avoid Them

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2022-09-29
- Length: 55m
- Episode: 282
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-09-29-7-common-510-k-mistakes-and-how-to-avoid-them
- Listen: https://podcast.greenlight.guru/episode/7-common-510k-mistakes-and-how-to-avoid-them

## Summary

Mike Drues, president of Vascular Sciences, joins host Jon Speer to discuss seven common mistakes in FDA 510(k) submissions based on Speer's earlier article. They cover critical errors such as inconsistent documentation, failure to use the Refuse to Accept (RTA) checklist, and insufficient testing data. The conversation also addresses the nuances of shelf-life claims for software and the strict requirements for demonstrating substantial equivalence to a predicate device.

## Chapters

- [0:58](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-09-29-7-common-510-k-mistakes-and-how-to-avoid-them#t=58) Introduction and Intended Use Inconsistencies
- [12:10](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-09-29-7-common-510-k-mistakes-and-how-to-avoid-them#t=730) Using the RTA Checklist and Avoiding Promissory Notes
- [23:02](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-09-29-7-common-510-k-mistakes-and-how-to-avoid-them#t=1382) Real-Time Shelf-Life Studies and Software as a Medical Device
- [32:11](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-09-29-7-common-510-k-mistakes-and-how-to-avoid-them#t=1931) Risk Management and Substantial Equivalence Requirements
- [39:45](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-09-29-7-common-510-k-mistakes-and-how-to-avoid-them#t=2385) Submission Formatting and Independent Review

## Topics

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

## Most relevant to

established companies

## Mentioned

- Green Light Guru (company)
- Vascular Sciences (company)
- FDA (other)
- ISO 14971 (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)
- [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)
- [155 - FDA Compliance Programs, Program 7536.000: CDER vs. CDRH led Inspections, Mock PAI's, Supplier Management, and What is a Manufacturer? with Laurie Auerbach](https://hardwarepodcasts.com/podcast/lets-combinate/2024-09-25-155-fda-compliance-programs-program-7536-000-cder-vs-cdrh-led-inspections-mock-p) (Let's Combinate)
- [217 - 5 Fixable Problems Holding Back Drug–Device Programs](https://hardwarepodcasts.com/podcast/lets-combinate/2025-12-10-217-5-fixable-problems-holding-back-drug-device-programs) (Let's Combinate)
- [IDology #11 - Most common mistakes in product development](https://hardwarepodcasts.com/podcast/idology/2023-03-28-idology-11-most-common-mistakes-in-product-development) (IDology)

## 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/2022-09-29-7-common-510-k-mistakes-and-how-to-avoid-them. 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.