The FDA approves electrical stimulation devices for sale in the United States for for "the symptomatic relief of chronic intractable pain and as an adjunctive treatment in the management of post surgical traumatic pain problems." Manufacturers of microcurrent and other electrical stim devices are only allowed to advertise and promote their devices for these approved uses. These are what would be called "on label" uses of the devices.
Medical devices and approved pharmaceutical drugs are often used by doctors for uses not approved by the FDA. These are called "off-label" uses. A high percentage of health care and esthetic practitioners use microcurrent devices for a wide range of off label uses, including non-needle acupuncture, treatment of macular degeneration and other eye diseases, facial rejuvenation, wound healing and fracture acceleration, TMJ syndrome alleviation and even relief of many internal organ and emotional disorders. These off-label applications are used with particular frequency by acupuncturists, who are used to using stimulation through the acupuncture meridian system for treatment of a host of physical and emotional diseases.
So the question is- are you within your legal rights to use your microcurrent stimulator for these off-label uses?
The term "IRB" refers to Investigational Review Board - a lengthy procedure required for proving new medical claims:
"Does FDA require IRB review of the off-label use of a marketed device?" YES, if the off-label use is part of a research project involving human subjects. NO, if the off-label use is intended to be solely the practice of medicine, i.e., for a physician treating a patient and no research is being done. The FDA recognizes that off-label use by prescribers is often appropriate and may represent the standard of practice."
There is a provision in the Federal Food, Drug, and Cosmetic Act that allows a practitioner to use a cleared device for an unapproved or 'off label' use." There are a number of restrictions that do apply in this case. The practitioner can only use the device "off label" in a legitimate practitioner-patient relationship. They may not advertise or promote the "off label" use of the device in their practice, and the manufacturer may not promote, advertise, or label the device for the "off label" use.
This is very clear. If you are a licensed health care practitioner whose scope of practice includes electrical stimulation, you may use a microcurrent device for any safe off-label application that you deem appropriate in the doctor-patient relationship. You are NOT legally allowed to advertise these off-label uses.
This advertising restriction only applies to advertising the electrical stim device for an off-label purpose. You can advertise treatment of any disease that you are legally allowed to treat. For acupuncturists or physicians, that is just about anything.
So what about microcurrent facial rejuvenation treatments? According to the FDA guidelines, you technically should not advertise the use of a FDA-registered microcurrent device for facial rejuvenation services, although you are free to use it with your patients. Yet the FDA does allow estheticians to advertise the use of microcurrent devices that are not FDA-registered for rejuvenation. They are the same technology! In actual practice the FDA has not bothered health care practitioners using or advertising microcurrent devices for facial rejuvenation due to these ambiguities. I have personally spoken with many FDA workers at various departments about this subject, and they all basically punt on the subject as they don't want to have to deal with it. The best opinion I could get was that it is OK to use microcurrent and light devices for rejuvenation as long as no medical claims are made for the procedure.
It would certainly be a no-no to use the word "face-lift" in any advertising, but rejuvenation, toning, revitalizing and similar words are perfectly OK.
For more information about microcurrent and light therapies visit http://www.eastwestseminars.com or call 1-888-803-7397
No comments:
Post a Comment