FDA frameworks, 361 vs 351, exosome regulation, state scope of practice, documentation standards, enforcement patterns, and a clinic setup checklist. 12 sections. Yours free.
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The four criteria for 361 vs 351, the same surgical procedure exception, and what happens when a product fails any criterion. Plain language, not legalese.
The 2019 FDA safety notification, what it means for clinical practice, and why "exosomes aren't regulated" is factually wrong.
FL, AZ, OK, WY, UT, GA, TN, NV -- the states with new laws, what each requires, and the national FSMB signal on where this is heading.
The six documents every compliant practice keeps: informed consent, treatment records, traceability, storage logs, adverse event reporting, deviation reports.
Real cases: FTC's $51M judgment against a Miami stem cell clinic, FDA warning letters, and the patterns regulators target first.
20+ items: entity, licensing, insurance, supplier vetting, HIPAA, OSHA, informed consent, traceability, compliance program, and more.
