Medical Devices vs. Drugs: Breaking Down FDA Pathways with IBAL Innovations

Welcome back to Health Unlocked! In today’s episode, Jasen Petersen explores a fascinating and refreshingly practical side of health innovation: how medical devices like IBAL are rewriting the rules of bringing new interventions to market. If you’ve ever wondered why some health-supporting products aren’t classified as drugs or supplements, or how the FDA draws that crucial line, you’ll love this discussion. Jasen, speaking from both professional and personal experience (post-lithotripsy, no less - ouch!), walks us through the surprising world of medical device regulation. He explains why IBAL, a micronutrient matrix designed to restore foundational cellular health, qualifies as a medical device rather than a drug and why that distinction could make innovative treatments far more accessible, affordable, and fast to reach those who need them most. Along the way, you’ll hear about strange regulatory quirks (like how toothpaste can be a cosmetic, a drug, or a device!), learn what it truly means for something to have a “PMI mechanism,” and get a behind-the-scenes look at how shifting the regulatory path from drugs to devices could transform healthcare innovation for both patients and investors. By the end, you’ll have a whole new appreciation for how creative science, regulatory strategy, and a bit of bold thinking can work together to unlock better health for everyone. Let’s dive in! Timestamps: 00:00 "IBAL: Redefining Medical Regulations" 04:23 "Foundations of Immune Healing" 08:50 Drug vs. Device Development Timelines 11:01 Drug vs Device Development Differences 15:20 Biotech Confidence in Non-PMI Drugs 20:01 IBAL Ingestion Risks and Alternatives 23:30 "Possibilities for Medical Innovation" 27:43 "Medical Device Outperforming Drugs" 28:48 Drug vs. Device Approval Risks 32:46 "Ion Gel Medical Device Approval" 36:07 Tokenized Research for Immune Continuum 39:26 "Grateful Acknowledgment" “Disclaimer: Informational only. Not medical advice. Consult your doctor for guidance.” Show Website - https://powerofsalutogenesis.com/ Ionic Alliance Foundation Website - https://iaf.care/ Jasen Petersen's LinkedIn - https://www.linkedin.com/in/jasenepetersen/ TopHealth Media Website - https://tophealth.care/