Hardware Podcasts

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

Let's Combinate · 24 Oct 2023 · 33m

What this episode covers

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and 513(g) classification processes, noting their timelines and costs, while advising companies to monitor draft guidance documents to anticipate FDA expectations during submissions.

Most relevant to

early-stage companies

Topics

Mentioned

Companies
leanRAQA
Products
LiveCore
Also
FDA, CDRH, 510(k), De Novo, PMA, 483

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