Informed consent documentation generally covers what is being done, what is known and not known about it, reasonable alternatives, and the risks the patient is accepting by proceeding. Where a product has not received FDA approval or clearance for the use in question, that fact itself is material information a patient would reasonably want before consenting, and several state experimental-treatment statutes require it to be stated directly rather than implied.
If a state experimental-treatment law applies to your practice, confirm whether its consent requirements go beyond general procedural consent. Florida's statute, for example, sets out disclosure elements tied to its own framework for physician use of certain non-FDA-approved stem cell therapies. A clinic operating under such a statute needs a consent process that meets the statute's specific elements, not just a general consent form adapted from an unrelated procedure.
Consent language, like clinical use decisions generally, sits with the treating physician and the clinic's own legal counsel. A distributor can share what documentation exists about a product, such as a certificate of analysis or donor eligibility summary, but cannot draft or approve a clinic's consent form, and does not provide medical or legal advice on how a given statute applies to a specific case.
Clinics using any non-FDA-approved product should build consent documentation around the specific disclosure requirements that apply in their state, rather than relying on a generic template. These products are not FDA approved or licensed for any disease or condition. Information is for licensed healthcare professionals and is not medical or legal advice.