Medical Devices 101: An Entry Level Overview of the FDA

In this practical session, Michelle breaks down how the FDA actually looks at medical devices—so you can choose the right pathway, budget for testing, and avoid dead-ends. You’ll learn the three device classes, the five steps to market, what “substantial equivalence” really means, when De Novo fits, and why “approval” ≠ “clearance.” If you’re leading a MedTech program this year, this talk is a no-nonsense roadmap to reduce surprises. Follow this sequence and the surprises shrink. 02:41 FDA risk-based classification (Class I–III + unclassified) 05:01 The “bread & butter”: QSR (21 CFR 820) + labeling/MDR 07:00 What exemptions still require (registration, listings, complaints) 09:03 The 5 steps to market 09:33 Intended Use vs. Indications for Use (lock them early) 12:27 Is it even a medical device? (definition & software nuance) 13:24 Claims make devices (lamp & depression example) 16:15 The “diapers” test (why adult can be a device) 18:12 Finding the pathway (FDA databases & product codes) 19:15 Surgical mask case (FXX vs. alternatives, NIOSH wrinkle) 24:34 Recognized standards & (maybe) third-party review 26:02 General standards you’ll still need (sterilization, biocomp, etc.) 26:02 Wellness vs. regulated (bruxism app scenarios) 30:01 Valid scientific evidence (bench, animals, clinical, HF/UX) 31:25 510(k) types & the SE argument 33:17 Words to avoid (“novel” can push you to De Novo) 36:35 Primary & reference predicates (don’t build a Frankenstein) 38:04 De Novo: when, why, and afterlife for others 41:24 Strategy: stage features & submissions 42:23 Time & money: realistic clocks, fees, testing budgets 43:24 PMA: what “approved” actually means 45:59 Authorization vs. clearance vs. approval 46:13 After clearance: QMS, claims review, and ongoing work 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. We’re also on Substack! https://leanraqa.substack.com/ 📩 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