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Amniotic Fluid, Amniotic Derived and Wharton’s Jelly products are classified by the Food and Drug Administration (FDA) as Human Cell, Tissue and Cellular and Tissue-Based Products (HCT/P) that are regulated solely under section 361 of the Public Health Service (PHS) Act. FDA recognizes that human tissue was designed, or evolved, to perform certain functions in the human body with exquisite safety and effectiveness. As an HCT/P regulated solely under Section 361 of the PHS Act, these products are exempt from FDA pre-market review, clearance, and approval from FDA. Please consult your doctor to see if an amniotic fluid injection is right for you. No medical advice has been offered herein. These statements have not been evaluated by the FDA. This product is not intended to diagnose, treat, cure or prevent any disease. Results may vary.

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