Regenerative medicine practices utilizing Platelet-Rich Plasma (PRP), bone marrow aspirate concentrate (BMAC), and cellular biologics operate in one of healthcare’s most volatile regulatory arenas. The FDA maintains strict boundaries between Section 361 Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)—which are exempt from premarket approval if minimally manipulated—and Section 351 biological drugs, which require investigational new drug (IND) applications. Misrepresenting biologic treatments or using unapproved perinatal or stem cell products can trigger severe FDA warning letters, state medical board sanctions, and catastrophic civil liability. Access Plus Health provides board-certified orthopedic, pain management, and physiatry physicians who serve as Medical Directors. We establish audit-proof clinical protocols focused strictly on FDA-compliant homologous use and minimal manipulation, create rigorous informed consent documentation, and institute comprehensive patient safety checks.