The Short Version
This resource center is for licensed physicians and clinic operators who want to understand how compliant adipose tissue banking fits into a modern practice. SaveMyFat is a connector that links providers and patients with a United States based tissue bank. It does not provide treatments and does not practice medicine. The pages gathered here cover the federal rules that govern human cells and tissues, the state laws that add disclosure and consent duties, the practice models physicians commonly use, the narrow pathways through which investigational products reach patients, and the advertising standards that keep a clinic on the right side of the Federal Trade Commission. Everything here is educational and reflects current guidance as of 2026. None of it is legal advice, and none of it substitutes for your own counsel or clinical judgment.
Important: This page is a professional education resource for licensed providers. It is not legal advice, not medical advice, and not a substitute for your own regulatory counsel. SaveMyFat is a connector that links providers and patients with a United States based tissue bank for adipose tissue banking. It does not collect, process, or store tissue itself and does not provide treatments or cures for any disease. Most adipose-derived cell products that are more than minimally manipulated are regulated as biologics and are not FDA-approved. Federal and state requirements change; confirm current obligations with primary sources and qualified counsel before acting.
What This Resource Center Is
Physicians who field patient questions about stem cells and regenerative medicine face a hard problem: the science is genuinely interesting, the marketing around it is often reckless, and the regulatory line between a lawful preservation service and an unapproved treatment is easy to cross with a single sentence. This center gathers the reference material a provider needs to stay on the right side of that line, organized the way a practice actually uses it.
SaveMyFat is a connector. It links your practice and your patients with a United States based tissue bank that performs adipose tissue banking under federal tissue regulations. It does not practice medicine, does not provide any therapy, and does not collect, process, or store tissue itself. You remain the treating clinician, responsible for every clinical decision and for compliance in your own state. What follows is not a sales script. It is a map to the primary rules, the practice models other providers use, the legitimate access pathways for investigational products, and the advertising standards that carry real enforcement risk. For the patient-facing overview of how referrals work, see the providers page. This page is reviewed quarterly.
Regulatory Compliance Resources
Every conversation with a patient rests on one federal distinction: whether a product is a Section 361 human cell and tissue product or a Section 351 biologic. Intact adipose tissue that is only cryopreserved may qualify under Section 361, which requires establishment registration and good tissue practices but not clinical trials. Enzyme-isolated stromal vascular fraction and culture-expanded cells generally fail the minimal manipulation or homologous use criteria and are regulated as investigational biologics that require an Investigational New Drug application. Getting this right protects both the patient and the practice.
Start with the two regulatory hubs, then use the focused explainers for the criteria that decide most cases:
- FDA Regulation of Adipose Tissue and Stem Cells, the plain-language framework for 361 versus 351, registration, and CGTP
- State Stem Cell Law Hub, the disclosure, consent, and advertising rules that vary by state
- What minimally manipulated really means under 1271
- Homologous use, the 361 criterion physicians cannot ignore
- FDA establishment registration for HCT/P providers
- Current Good Tissue Practice and the FDA lab standard
The primary sources sit behind all of these: 21 CFR Part 1271 and the FDA Consumer Alert on Regenerative Medicine Products. When a patient asks whether something is FDA-approved, the honest answer is that the only approved stem cell products in the United States are cord-blood forming cells for certain blood disorders, and adipose-derived products for other uses are investigational.
Practice Model Resources
Adipose tissue banking shows up in several kinds of practice, and the compliance emphasis shifts with each. The table below summarizes the common settings. In every one of them, the same discipline applies: banking is a preservation service, not a treatment, and nothing about storing tissue guarantees future access or benefit.
For deeper reading on the two models providers ask about most, see how stem cell banking fits into a cash-pay practice and sports medicine physicians and stem cell banking. Both keep the framing where it belongs, on preservation and patient education, rather than on outcomes no one can promise.
Expanded Access and IRB Pathways
Patients sometimes ask how they could actually receive an investigational adipose product. It is worth being precise, because the honest answer protects them from clinics that blur the line. There are three narrow routes, and none is a retail treatment. A registered clinical trial studies a product under an Investigational New Drug application with informed consent and Institutional Review Board oversight. The FDA Expanded Access program, sometimes called compassionate use, can allow a seriously ill patient to receive an investigational product outside a trial when no comparable option exists and the FDA, the sponsor, and the treating physician all agree. Right to Try is a separate federal pathway with its own criteria.
Physicians who want to understand the mechanics, including how an IND submission works and how IRB review differs from mere investigational labeling, will find these useful: a physician’s guide to Expanded Access and how to submit an IND and IRB approval versus investigational status. For the current trial landscape, the clinical trials directory lists active adipose-related studies with verified registration numbers, and ClinicalTrials.gov is the primary source. Banking tissue does not enroll a patient in any program; it preserves an option that a lawful pathway might one day use.
Marketing Compliance Resources
The fastest way for a compliant practice to create liability is careless advertising. The Federal Trade Commission treats every health claim, testimonial, and review as an ad, and its Health Products Compliance Guidance requires that claims be truthful, not misleading in their overall impression, and backed by competent and reliable scientific evidence before they are published. Disease-treatment claims for unapproved products, the words cure or heal, calling an investigational product FDA-approved, guaranteed outcomes, and urgency tactics are the categories that draw enforcement.
Use the dedicated Compliant Marketing Standards hub for the substantiation and testimonial rules, the state advertising notices, the platform policies for Google and Meta, and a side-by-side of compliant versus non-compliant language. To see how enforcement actually plays out, read the FTC stem cell enforcement pattern and what it means, and share how to spot fake stem cell clinics with patients who are shopping around. Teaching patients the red flags is both good medicine and good positioning.