What you will learn
- The FDA framework: 21 CFR 1271, 361 vs 351
- Exosome regulation and the enforcement reality
- IND, IDE, RMAT, and expanded access pathways
- State-by-state landscape and scope of practice
- Documentation standards and informed consent
- Adverse event reporting and deviation reporting
- The compliance program every clinic should run
- Malpractice insurance for regenerative practices
Curriculum
Module 1 — Science: What HCT/Ps and Exosomes Are
2 sections ▼
- The vocabulary: HCT/P, exosome, autologous, allogeneic 13 min
- Why "stem cell therapy" is not a product 12 min
Module 2 — Evidence: Proven vs Investigational
2 sections ▼
- The evidence ladder: label, peer-reviewed, research 13 min
- Approved vs reviewed vs "research shows" 12 min
Module 3 — The FDA Framework
3 sections ▼
- The 361 vs 351 decision 15 min
- Same surgical procedure exception, IND, RMAT 15 min
- cGTP, registration, records, deviations 15 min
Module 4 — Enforcement Reality
2 sections ▼
- The agencies and the cases: FTC, FDA, boards 15 min
- The patterns and the 2019 exosome moment 15 min
Module 5 — The State-by-State Landscape
3 sections ▼
- The national picture and FSMB signal 12 min
- States with new laws: FL, AZ, OK, WY, UT, GA, TN, NV 14 min
- Scope of practice: verify YOUR license in YOUR state 14 min
Module 6 — Documentation & Informed Consent
3 sections ▼
- The six-part documentation stack 14 min
- Informed consent done right 14 min
- Research vs treatment and adverse event channels 12 min
Module 7 — The Compliance Program & Insurance
2 sections ▼
- The seven OIG compliance components 15 min
- Insurance: the coverage that changes everything 15 min
Module 8 — Case Studies: Spot the Violation
2 sections + final exam ▼
- Three real-pattern clinic audits 16 min
- The corrective action plan 14 min
- Scenario-based final assessment (80% to pass)
Who this is for
Physicians, NPs, PAs, and RNs offering or planning to offer regenerative therapies: exosomes, stem cell products, PRP, peptides, and biologics. If you are in this field, this course is the professional floor. It is also the smartest first purchase a new regenerative clinic makes.
