Can I advertise a non-FDA approved medical treatment that uses a non-FDA approved device?
By admin on Feb 17, 2009 in Alternative Medicine
C S asked:
I would like to start offering a treatment to patients (I am a physician) that utilizes a device that is not FDA approved. Therefore the treatment is not FDA approved, either.
Anyone have any words of wisdom?
I would like to start offering a treatment to patients (I am a physician) that utilizes a device that is not FDA approved. Therefore the treatment is not FDA approved, either.
The treatment is using transcranial direct current stimulation (tDCS, more here at my blog http://brainmagnets.blogspot.com/ ) for a therapeutic purpose. I am trained in the technique and the side-effect profile is essentially benign, if done properly.
I would like to start offering a treatment to patients (I am a physician) that utilizes a device that is not FDA approved. Therefore the treatment is not FDA approved, either.
Anyone have any words of wisdom?
I would like to start offering a treatment to patients (I am a physician) that utilizes a device that is not FDA approved. Therefore the treatment is not FDA approved, either.
The treatment is using transcranial direct current stimulation (tDCS, more here at my blog http://brainmagnets.blogspot.com/ ) for a therapeutic purpose. I am trained in the technique and the side-effect profile is essentially benign, if done properly.
On Feb 17, 2009, Onix G said:
Most alternative treatments aren’t FDA approved are they? I am in Canada so I’m no expert when it comes to what can be done in the states but I do know that there are quite a few alternatives that aren’t FDA approved and are advertised. Have you written a paper on your treatment and findings?
On Feb 20, 2009, joecool said:
Try informed consent it works for me. Also depends on which part of the country you practice in. Many items in health care are not approved and eventually become approved at a later date. Risk versus reward and informed consent is the caveat.
You did not mention what it was.
On Feb 23, 2009, Laura J said:
Well, its not FDA approved because its not toxic, there are no side affects etc… However, you get consent as a practitioner and practice with no slings and arrows from your colleagues, then it should be O.K.
The state of Texas has been really naughty lately. A physician who cured many of his patients who had cancer with no chemotherapy is under investigation and they are trying to shut him down. They are ignoring the DSHEA Law which protects people like you, so state regulatory laws in TX seem to be completely separate from our Union these days.
So, I don’t know where you practice, but I work with health care practitioners who use natural means successfully and none of these things are FDA approved because there is no toxicity levels to define them as treatments.
Thus, the premise is what makes the body heals the body and your device works with stimulating the natural healing process of the body in one specific technique. I see no harm in utilizing this in your practice.
Just make sure you get consent forms and if you are successful at improving quality of life, then your going to get more patients through word of mouth.
On Feb 26, 2009, susandorey said:
lol, looks to me like you just did advertise your service.
On Feb 28, 2009, Alex F said:
Judging from what I’ve seen other people do, you have to put a clear disclaimer in your advertisement that it’s not FDA approved, you are not claiming it will have a medical result, and rather you are reccomending it to people for them to try (but not stating that it will definitively work) because you found it waa pretty awesome.
If you believe no negative side effects can occur, it’s probably fine to list that as well.