Regenerative medicine,sourced for licensed practices.

Important regulatory information

FDA disclaimers. Please read before you enquire.

1. No product discussed on this page is approved by the FDA to diagnose, treat, cure or prevent any disease or condition.
2. The regulatory status of regenerative and cell-based products depends on the specific product and its intended use. FDA regulates human cells, tissues, and cellular and tissue-based products (HCT/Ps) under 21 CFR Part 1271.21 CFR Part 1271 A product that is more than minimally manipulated, or is used for something other than its homologous use, is regulated as a drug or biologic and needs FDA approval before it may be lawfully marketed for that use.FDA HCT/P guidance
3. This page and these products are for licensed healthcare professionals and licensed practices only. Nothing here is intended for patients or consumers, and nothing here is medical advice.
4. The practitioner is solely responsible for deciding whether and how any product is appropriate to use, for informed patient consent, and for complying with every federal, state and local law that applies, including licensing and scope of practice rules.
5. California: Business and Professions Code section 684 requires a health care practitioner who performs stem cell therapies not approved by the FDA to give patients a prescribed notice, both as a prominent display in an area visible to patients in the office and in writing before the first therapy.Cal. B&P Code 684 Other states may have their own rules. Check the current requirements with your counsel.
6. We make no claims about indications, outcomes or effectiveness, and nothing on this page should be read as one. FDA publishes information for patients about regenerative medicine products.FDA consumer notice