Florida podiatric physicians may use certain FDA-unapproved products for specified treatments, if they meet safety checks and patients sign consent forms.
Podiatric physicians may use certain FDA-unapproved products for specified treatments, if the products meet requirements for their facilities, certification, and live cells.
For covered procedures, podiatric physicians must advertise that the products lack FDA approval and get signed consent after explaining the treatment, risks, benefits, and alternatives.
The board may discipline physicians who violate this section. Willfully taking part in specified fetal-tissue treatment or research, or certain computer-product activities, is a third-degree felony.
Podiatric physicians may use certain products that the FDA has not approved for specified treatments. The treatment must be within the physician’s scope of practice and relate to connective tissue, ligament, or tendon repair, wound care, or pain management. Products must come from facilities registered and regulated by the FDA and certified or accredited by a listed organization. Products must contain live cells after thawing, and the physician must receive a report confirming this before use.
Podiatric physicians must include an FDA status notice in advertisements and get signed patient consent before treatment. These duties apply when a podiatric physician performs a covered procedure. The patient signs the form, or a representative signs if the patient is not legally competent. The notice must be easy to read and at least as large as the largest type in the advertisement. The consent must explain the treatment, expected results, serious possible risks and benefits, and alternatives, including no treatment. It must encourage the patient to consult a primary care provider. The patient or the patient’s representative must sign the consent before the procedure.
The Board of Podiatric Medicine may discipline a physician for a violation; willfully taking part in specified conduct is a third-degree felony. A violation may lead to discipline by the Board of Podiatric Medicine. The felony applies to willfully performing or actively taking part in treatment or research using cells or tissues from a fetus or embryo after an abortion, or selling, making, or distributing computer products created using human cells, tissues, or related products. This section does not apply to physicians with FDA approval for an investigational drug or device, or to physicians performing procedures under contract for institutions accredited by a listed organization.
No hearings or votes scheduled.