How to Speak FDA (Without a Translator) | Device & Conquer | S2:E1

About this episode

The episode discusses the unique language of the FDA and how medtech professionals can effectively communicate within regulatory frameworks.

Think you speak English? The FDA might disagree. In the Season 2 kickoff of Device &Conquer , hosts Michelle Lott and Tianna Benson break down the unique language of the U.S. Food and Drug Administration — a dialect every medtech professional needs to understand to survive regulatory conversations. From decoding words like “should,” “non-binding,” and “substantial equivalence” to navigating claims, AI buzzwords, and “inherent use,” this episode reveals why context, punctuation, and phrasing can make or break your FDA submission. You’ll learn: Why “should” really means “shall” in FDA guidance How to argue (and win) your case using the right regulatory language What “substantial equivalence” actually means (and doesn’t) Why saying your product uses “AI” might double your review time The hidden meaning of “general wellness” and “inherent use” How punctuation can change compliance outcomes Whether you’re a startup founder or seasoned QA/RA pro, this is your crash course in how to speak FDA — without a translator. Listen, laugh, and learn as Michelle and Tianna pour a cocktail and translate regulatory jargon into plain English. Watch the video on YouTube…

People in this episode

Hosts: Michelle Lott, Tianna Benson

Topics covered

• FDA language
• regulatory compliance
• medtech
• substantial equivalence
• AI in medical devices
• regulatory jargon

Keywords

• FDA
• regulatory language
• medtech
• substantial equivalence
• AI
• compliance
• general wellness

Mentioned in this episode

Organizations: U.S. Food and Drug Administration

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