Hardware Podcasts

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

Let's Combinate · 22 Mar 2023 · 22m

What this episode covers

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.

Most relevant to

early-stage companies

Topics

Mentioned

Companies
leanRAQA
Tools
CDRH Learn, Product Classification Database, 510(k) Database, Registration and Listing Database, Total Product Life Cycle, Guidance Document Database, CFR Title 21

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