# 106 - FOIA, FDA Modernizing 510(k) Program, De Novo Submissions, and more databases with Michelle Lott

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2023-10-24
- Length: 33m
- Page: https://hardwarepodcasts.com/podcast/lets-combinate/2023-10-24-106-foia-fda-modernizing-510-k-program-de-novo-submissions-and-more-databases-wi
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/106---FOIA--FDA-Modernizing-510k-Program--De-Novo-Submissions--and-more-databases-with-Michelle-Lott-e2anifq

## Summary

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and 513(g) classification processes, noting their timelines and costs, while advising companies to monitor draft guidance documents to anticipate FDA expectations during submissions.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/lets-combinate/2023-10-24-106-foia-fda-modernizing-510-k-program-de-novo-submissions-and-more-databases-wi#t=0) Introduction: Michelle Lott and leanRAQA
- [2:03](https://hardwarepodcasts.com/podcast/lets-combinate/2023-10-24-106-foia-fda-modernizing-510-k-program-de-novo-submissions-and-more-databases-wi#t=123) FOIA Process and 510(k) Summaries vs. Statements
- [7:18](https://hardwarepodcasts.com/podcast/lets-combinate/2023-10-24-106-foia-fda-modernizing-510-k-program-de-novo-submissions-and-more-databases-wi#t=438) Using 483 and Warning Letter Databases for Regulatory Intelligence
- [12:53](https://hardwarepodcasts.com/podcast/lets-combinate/2023-10-24-106-foia-fda-modernizing-510-k-program-de-novo-submissions-and-more-databases-wi#t=773) Accessing Redacted FOIA 510(k) Submissions Online
- [18:44](https://hardwarepodcasts.com/podcast/lets-combinate/2023-10-24-106-foia-fda-modernizing-510-k-program-de-novo-submissions-and-more-databases-wi#t=1124) FDA 510(k) Modernization: Predicate Selection and Clinical Data
- [22:41](https://hardwarepodcasts.com/podcast/lets-combinate/2023-10-24-106-foia-fda-modernizing-510-k-program-de-novo-submissions-and-more-databases-wi#t=1361) De Novo Pathway vs. 510(k) and New Regulation Creation
- [28:25](https://hardwarepodcasts.com/podcast/lets-combinate/2023-10-24-106-foia-fda-modernizing-510-k-program-de-novo-submissions-and-more-databases-wi#t=1705) Pre-Submission and 513(g) Classification Requests
- [30:50](https://hardwarepodcasts.com/podcast/lets-combinate/2023-10-24-106-foia-fda-modernizing-510-k-program-de-novo-submissions-and-more-databases-wi#t=1850) Navigating Draft Guidance and Submission Strategy

## Topics

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

## Most relevant to

early-stage companies

## Mentioned

- leanRAQA (company)
- FDA (other)
- CDRH (other)
- 510(k) (other)
- De Novo (other)
- PMA (other)
- 483 (other)
- LiveCore (product)

## Related episodes from other shows

- [Demystifying the De Novo Process](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-05-12-demystifying-the-de-novo-process) (Global Medical Device Podcast)
- [#342: Planning an FDA Submission](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-11-02-342-planning-an-fda-submission) (Global Medical Device Podcast)
- [#346: FDAs eSTAR Program](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-11-30-346-fdas-estar-program) (Global Medical Device Podcast)
- [510(k) Tips and Answers to Frequently Asked Questions for Medical Device Companies](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-05-06-510-k-tips-and-answers-to-frequently-asked-questions-for-medical-device-companie) (Global Medical Device Podcast)
- [How to Choose the Right FDA Regulatory Pathway for your Device](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-02-26-how-to-choose-the-right-fda-regulatory-pathway-for-your-device) (Global Medical Device Podcast)

## Citing this page

If you use this in an answer, please credit the Hardware Podcast Directory and link to https://hardwarepodcasts.com/podcast/lets-combinate/2023-10-24-106-foia-fda-modernizing-510-k-program-de-novo-submissions-and-more-databases-wi. 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 Let's Combinate.