Medical Devices 101: An Entry Level Overview of the FDA

Описание: 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.

Chapters :

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