GG&G

[Simpsonly]

Posted as 84776 related to medical devices . . .



I find two things very encouraging about the post below which indicate that FDA is on top of its progress with clearing the ActiPatch for OTC sales in the USA:

(1) Apparently part of a written response by FDA - "Below provides information regarding situations for which this might be allowed:
-> Product is not for treatment of a serious condition and there is no known significant health risk."

I love it - "where there is no known significant health risk."
Setter words were never written - ActiPatch - >1Million devices used by members of the public = no negative side-effects = no risk . . . and

(2)

The FDA does not regulate the practice of medicine. Therefore if a doctor writes a prescription for this device for the relief of back pain, FDA clearance for that specific use is not required prior to your purchasing the product.

Soooo, just have your physician write an RX with 2 lines on it - whatever drug he or she is risking your life with and the second for ActiPatch which will help to manage your pain effectively without risk . . . .



Posted by: GetSeriousOK
In reply to: DewmBoom who wrote msg# 84749 Date:9/25/2016 12:52:00 PM
Post #84758 of 84774



I don't believe you. Instead, I choose to believe my correspondence with the FDA on September 6th and 7th. These are direct quotes:

ME:

I am confused about the ActiPatch device made by the BioElectronics company. The company tells me that I can buy the device to use for the indication of back pain if I get a prescription from a doctor.

However, it looks to me like the only prescription I can get for this device is for the indication of swelling after blepharoplasty.

Here is the link to the device:

https://accessgudid.nlm.nih.gov/devices/00851329005050

Can I legally buy this device in the USA and use it for back pain if I get a doctors prescription?

And if not, I see this device for sale on eBay, shipped from England where the device is legally sold OTC. Is it legal for me to buy it this way on eBay and have it shipped to me in the USA for use on my back pain? If not, who would be breaking the law -- me, the U.K. seller, or both of Us?

Below provides information regarding situations for which this might be allowed:
-> Product is not for treatment of a serious condition and there is no known significant health risk.


THE FDA:

I do not see an FDA clearance for the ActiPatch. If you would like to personally import the ActiPatch into the United States it would be considered an unapproved device.
FDA has guidance for personal importation of drug or device products.

ME:

The device is cleared by the FDA under the name "ActiBand" for the indication of swelling after blepharoplasty. It's the same device with a different name. The URL I sent you makes it look like the device is also cleared for the indication of back pain, with a prescription. So just to clarify: I cannot buy the ActiPatch in the USA for use on my back pain, even if I get a US doctor's prescription?

Because the company told me I could and offered to help me fill out the paperwork. So I am confused.

THE FDA:

The FDA does not regulate the practice of medicine. Therefore if a doctor writes a prescription for this device for the relief of back pain, FDA clearance for that specific use is not required prior to your purchasing the product.