Regulatory status depends on the product, processing, intended use, and other facts. Do not assume a product is FDA approved, FDA cleared, FDA compliant, a Section 361 product, or exempt from approval. Ask for documentation. This guide does not establish that a proposed product contains stem cells, mesenchymal stem cells, exosomes, or a particular tissue or cell source.
FDA states that regenerative medicine products marketed as stem-cell, Wharton’s jelly, amniotic, exosome, and similar products have not been FDA-approved for orthopedic conditions such as osteoarthritis, tendonitis, disc disease, and back, hip, knee, neck, or shoulder pain. This does not mean every product is identical; it means patients need exact product and intended-use information.
Cellular or tissue-based therapy is not presented as regenerating cartilage, repairing discs, reversing arthritis, restoring joints, healing tendons, replacing surgery, or producing predictable pain relief.