# 077 - 8 Databases and How To Use Them with Michelle Lott

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2023-03-22
- Length: 22m
- Page: https://hardwarepodcasts.com/podcast/lets-combinate/2023-03-22-077-8-databases-and-how-to-use-them-with-michelle-lott
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/077---8-Databases-and-How-To-Use-Them-with-Michelle-Lott-e20oem2

## Summary

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.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/lets-combinate/2023-03-22-077-8-databases-and-how-to-use-them-with-michelle-lott#t=0) Introduction: Michelle Lott and leanRAQA
- [1:33](https://hardwarepodcasts.com/podcast/lets-combinate/2023-03-22-077-8-databases-and-how-to-use-them-with-michelle-lott#t=93) CDRH Learn: Training and Webinar Resources
- [3:46](https://hardwarepodcasts.com/podcast/lets-combinate/2023-03-22-077-8-databases-and-how-to-use-them-with-michelle-lott#t=226) Product Classification Database and 510(k) Exemptions
- [7:38](https://hardwarepodcasts.com/podcast/lets-combinate/2023-03-22-077-8-databases-and-how-to-use-them-with-michelle-lott#t=458) 510(k) Database and FOIA Redactions
- [11:55](https://hardwarepodcasts.com/podcast/lets-combinate/2023-03-22-077-8-databases-and-how-to-use-them-with-michelle-lott#t=715) Registration and Listing Database for Competitor Analysis
- [13:57](https://hardwarepodcasts.com/podcast/lets-combinate/2023-03-22-077-8-databases-and-how-to-use-them-with-michelle-lott#t=837) Total Product Life Cycle (TPLC) and Adverse Events
- [16:20](https://hardwarepodcasts.com/podcast/lets-combinate/2023-03-22-077-8-databases-and-how-to-use-them-with-michelle-lott#t=980) Guidance Document Database and Product-Specific Rules
- [20:16](https://hardwarepodcasts.com/podcast/lets-combinate/2023-03-22-077-8-databases-and-how-to-use-them-with-michelle-lott#t=1216) CFR Title 21 and Other Submission Databases

## Topics

- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)

## Most relevant to

early-stage companies

## Mentioned

- leanRAQA (company)
- CDRH Learn (tool)
- Product Classification Database (tool)
- 510(k) Database (tool)
- Registration and Listing Database (tool)
- Total Product Life Cycle (tool)
- Guidance Document Database (tool)
- CFR Title 21 (tool)

## Related episodes from other shows

- [Understanding and Handling Different Types of Feedback](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-01-14-understanding-and-handling-different-types-of-feedback) (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)
- [#404: MedTech 101: What You Need to Know About the Medical Device Industry](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2025-05-01-404-medtech-101-what-you-need-to-know-about-the-medical-device-industry) (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)
- [#410: Is the MAUDE Database Broken? An Insider’s Take on Adverse Event Reporting Failures](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2025-06-09-410-is-the-maude-database-broken-an-insiders-take-on-adverse-event-reporting-fai) (Global Medical Device Podcast)

## Citing this page

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