How to Speak FDA Without a Translator | Decoding Regulatory Language | Device & Conquer (S2 Ep. 1) скачать в хорошем качестве

How to Speak FDA Without a Translator | Decoding Regulatory Language | Device & Conquer (S2 Ep. 1)

Welcome to Season 2 of Device & Conquer! In this episode, Michelle and Ti decode the mysterious dialect of the FDA — because reading English doesn’t mean you speak FDA. Learn how to interpret common regulatory terms, avoid rookie mistakes, and respond effectively to the agency’s feedback. From “should” vs. “shall” to “substantial equivalence” and “inherent use,” this episode is your roadmap to communicating confidently with FDA reviewers. In this episode, you’ll learn: What “should,” “non-binding,” and “guidance” really mean How to justify deviations from FDA recommendations The two-part test for substantial equivalence (intended use + technology) Why AI, wearables, and wellness claims can trigger a 510(k) upgrade The danger of “inherent use” — claims you didn’t make but FDA sees anyway Why punctuation and phrasing matter more than you think Practical tips for mirroring FDA’s own language in your responses Timestamps: 00:50 – The “how-to” season: practical regulatory tactics 01:06 – Why you need to learn how to speak FDA 01:43 – The first magic word: “should” (and why it means “must”) 02:25 – Non-binding ≠ optional — how to interpret guidance correctly 03:00 – What FDA guidance documents really mean 04:17 – “Substantial equivalence” — deeper than it sounds 05:25 – How to prove intended use and technological characteristics 06:20 – Why “same, similar, different” is FDA’s favorite framework 07:20 – The tightrope between regulatory and marketing claims 08:00 – The AI trap: when “smart” becomes “submission required” 09:00 – Wellness devices and the limits of “enforcement discretion” 10:00 – From Fitbit to Apple Watch: when features become medical claims 11:10 – Real-world case: Owlet Sock and the cardiac monitor controversy 12:14 – FDA trolling your website for unapproved claims 13:00 – “Inherent use” explained — and why it’s a hidden compliance risk 14:13 – Real examples of implied claims and misbranding warnings 15:49 – When language triggers new claims without saying a word 16:27 – Draft guidances: “still draft” doesn’t mean optional 17:29 – Climbing the wrong hill — knowing when to stop arguing 18:20 – The punctuation problem: commas can kill a submission 19:30 – “Process” vs. “procedure” — FDA’s contextual trap 20:03 – How to mirror FDA language and cite guidance effectively 21:00 – What RAQA really means (and why you should know) Subscribe to the Device & Conquer podcast for bold, insightful conversations that make medtech regulation make sense: https://open.spotify.com/episode/6Dfh... And be sure to like and subscribe for even more insights on medical device regulations, compliance, and quality systems (it will be fun and not painful, I promise). Visit us at https://leanraqa.com/ for even more regulatory goodness and to learn more about our services. 📩 Got a question or a topic for a future session? Drop it in the comments below! #FDA #RegulatoryAffairs #MedicalDevices #MedTech #Compliance #PreSub #QualitySystems #submissions #commercialization #startups #productlaunches #businessdevelopment