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

Podcast episode cover

October 24, 2023

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

Share

Show Notes

On this episode, Michelle Lott of LeanRAQA walks the listeners through 8 FDA Databases and how to use them!

If you'd like to hear more about Michelle checkout episode 031, 077, checkout Michelle's Blog @ LeanRAQA.com and Michelle's Podcast RAQA Today.

Michelle Lott is the founder and principal of leanRAQA, which has supported 100+ companies with regulatory strategy, regulatory submissions, quality systems compliance, FDA audits, due diligence, technical support services – (and grief counseling, because dealing with regulators can be emotionally draining!). She has served on the FDA Device Good Manufacturing Practices Advisory Committee and is a vocal advocate of EU MDR readiness. Michelle serves the medical device, dietary supplements, biologics, pharmaceutical, cosmetics, and food industries.

Resources

Join Our news Letter

By signing up, you agree to receive email from this podcast.

Recent Episodes

July 15, 2026

246 – The 3 Ways to Structure a Quality Management System (Centralized vs. Federated vs. Decentralized)

July 8, 2026

245 – Reducing a 14-Step Emergency Injection to a Two-Step Auto-Injector

July 1, 2026

244 – 5 Critical Quality Differences Between Drugs and Devices

Join Our newsletter

Sign up now to stay ahead with our combo product tips and never miss a weekly episode!

By signing up, you agree to receive email from this website.