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How to Build a 510(k) Without Losing Your Mind | Device & Conquer | S2:E3

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Manage episode 517591834 series 2446473
Content provided by Michelle Lott. All podcast content including episodes, graphics, and podcast descriptions are uploaded and provided directly by Michelle Lott or their podcast platform partner. If you believe someone is using your copyrighted work without your permission, you can follow the process outlined here https://podcastplayer.com/legal.

Building a 510(k) isn’t just about filling in forms — it’s about telling the FDA a story they can’t say no to.In this episode of Device & Conquer, Michelle Lott and Tianna Benson unpack what really goes into preparing an FDA 510(k) submission — from substantial equivalence and predicate devices to the eSTAR template, testing requirements, and why your submission is basically a regulatory novel.

They also cover the difference between traditional, special, and abbreviated 510(k) pathways, the myths around timelines, and why “just throw money at it” never works when you’re waiting on biocompatibility results.

In this episode, you’ll learn:

  • How to structure your 510(k) as a cohesive “story”

  • What FDA reviewers actually look for (and what confuses them)

  • The role of risk management, human factors, and performance testing

  • What the eSTAR template really does — and doesn’t — simplify

  • When to use special vs. traditional 510(k) submissions

  • How to avoid common rookie mistakes and review delays

    • Why patience, precision, and planning matter more than funding

    Watch the video on YouTube: https://youtu.be/1XuGuLRsFyY

    Be sure to subscribe to the Device & Conquer podcast forbold, insightful conversations that make medtech regulation make sense.

    Visit us at https://leanraqa.com/ for even more regulatory goodness and to learn more about our services.
    📩Got a question or a topic for a future session? Drop it in the comments below!
    #productlaunches#businessdevelopment

    for even more regulatory goodness andto learn more about our services.
    📩Gota question or a topic for a future session? Drop it in the comments below!
    #FDA #RegulatoryAffairs #MedicalDevices #MedTech #Compliance#PreSub#QualitySystems #submissions #commercialization #startups#productlaunches#businessdevelopment

  •   continue reading

    61 episodes

    Artwork
    iconShare
     
    Manage episode 517591834 series 2446473
    Content provided by Michelle Lott. All podcast content including episodes, graphics, and podcast descriptions are uploaded and provided directly by Michelle Lott or their podcast platform partner. If you believe someone is using your copyrighted work without your permission, you can follow the process outlined here https://podcastplayer.com/legal.

    Building a 510(k) isn’t just about filling in forms — it’s about telling the FDA a story they can’t say no to.In this episode of Device & Conquer, Michelle Lott and Tianna Benson unpack what really goes into preparing an FDA 510(k) submission — from substantial equivalence and predicate devices to the eSTAR template, testing requirements, and why your submission is basically a regulatory novel.

    They also cover the difference between traditional, special, and abbreviated 510(k) pathways, the myths around timelines, and why “just throw money at it” never works when you’re waiting on biocompatibility results.

    In this episode, you’ll learn:

    • How to structure your 510(k) as a cohesive “story”

    • What FDA reviewers actually look for (and what confuses them)

    • The role of risk management, human factors, and performance testing

    • What the eSTAR template really does — and doesn’t — simplify

    • When to use special vs. traditional 510(k) submissions

    • How to avoid common rookie mistakes and review delays

    • Why patience, precision, and planning matter more than funding

    Watch the video on YouTube: https://youtu.be/1XuGuLRsFyY

    Be sure to subscribe to the Device & Conquer podcast forbold, insightful conversations that make medtech regulation make sense.

    Visit us at https://leanraqa.com/ for even more regulatory goodness and to learn more about our services.
    📩Got a question or a topic for a future session? Drop it in the comments below!
    #productlaunches#businessdevelopment

    for even more regulatory goodness andto learn more about our services.
    📩Gota question or a topic for a future session? Drop it in the comments below!
    #FDA #RegulatoryAffairs #MedicalDevices #MedTech #Compliance#PreSub#QualitySystems #submissions #commercialization #startups#productlaunches#businessdevelopment

  •   continue reading

    61 episodes

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