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: https://youtu.be/lCICbNHgt4I