Off-Label Use of Lasers by Podiatrists
Podiatrists in Texas can treat the foot by "any system or method", which may include the use of a laser device.
Laser devices must be used safely for their intended purpose, be properly registered with Texas Department of State Health Services, and not prohibited by any other regulatory agency.
Regulation of Lasers
The use of lasers are subject not only to Podiatry Regulations, but also to those of the Texas Department of State Health Services, the Texas Medical Board, the Texas Spa Act and the U.S. Food & Drug Administration (FDA), as well as TDLR rules related to cosmetology.
Advertising
Medical providers are restricted from advertising or promoting an off-label indication to attract patients for an off-label procedure; such promotion and inducement of an off-label therapy is misleading/deceptive.
The podiatrist can, however, advise a patient seeking treatment of the off-label medication or device when the patient presents with a condition for which the podiatrist determines that the off-label medication or device is in the patient's best interest.
Patient Consent
Patients should be notified by the Podiatrist of any off-label use of drugs and devices, and informed consent should be obtained for the safety of the patient.
The American Podiatric Medical Association (APMA) provides the following refresher on "Off-Label" Use of Marketed Drugs and Medical Devices:
“Sound medical practice and the best interests of the patient require that podiatrists use legally available drugs and devices according to their best knowledge and judgment. However, podiatrists may routinely utilize a Food and Drug Administration (FDA)-approved drug or medical device to treat a condition or perform a surgical procedure for which the product has not yet been approved. Podiatrists may receive information about the success of such off-label use from colleagues, seminars, medical literature, and, in some cases, from the manufacturer itself. In these cases, the podiatrist has the responsibility to be well-informed about the product; to base its use on firm, scientific rationale and on sound medical evidence; and to maintain records of the product's use and effects. When using a drug or device for an off-label use, DPMs should inform the patient of this use, advise the patient of possible complications, and document this conversation in the patient's medical record.”
Further Help and Guidance
If you have questions about the appropriateness of devices used in your practice, visit fda.gov for more information.
