Is Smoking Cessation Device a Medical Device?

N

nafisahbegum

#11
Dear AL Rosen & Atetsade,

Thank you for all your inputs.

I am aware that the advice from Atetsade was with reference to TENS device already listed/registered, however with the indication for pain control.

I also understand that there is no relevant predicate device to compare with to date based on my research on the FDA site, pertaining to the device i highlighted.

Basically the design and concept of the device is very simialr to a TENS device except for the intended use. We were wondering if anyone knows of an aternative route we could register the device with FDA if not through PMA. Considering the risk classification and device classification it does not seem justified for the device to be subjected to a PMA evaluation, just because its intended use is different. Does anyone have any experience with SECTION 513(F)(2) - Evaluation of Automatic Class III Designation, Guidance for Industry & CDRH Staff.

Thank you all for your advice. And AL, your kind advice is noted.
 
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Al Rosen

Staff member
Super Moderator
#12
atetsade said:
That's true, Al. Thanks for the correction.

Does the device actually help people stop smoking?
I believe that some studies that have been done have shown that these types of devices are within the effectiveness of a placebo. I doubt approval will be forthcoming any time soon.
 

Jim Wynne

Staff member
Admin
#13
Al Rosen said:
I believe that some studies that have been done have shown that these types of devices are within the effectiveness of a placebo. I doubt approval will be forthcoming any time soon.
A little :topic: but...

I read a few months ago about a study that compared the effects of fake acupuncture (using collapsing needles that didn't actually penetrate) versus a placebo pill for certain types of pain. The somewhat surprising result was that fake acupuncture proved more effective than fake pills, with a tentative hypothesis being that treatments that are significantly ritualized (i.e., ones that involve doctors actually doing a lot of stuff) seem to be more effective than passive modes of treatment, regardless of whether there is any real intrinsic therapeutic value in the treatment.

It's also interesting to note that a significant number of subjects (in both groups) reported side effects from the fake treatments, and the side effects were the same ones that the subjects were informed of before the study began.
 

Al Rosen

Staff member
Super Moderator
#14
nafisahbegum said:
Dear AL Rosen & Atetsade,

Thank you for all your inputs.

I am aware that the advice from Atetsade was with reference to TENS device already listed/registered, however with the indication for pain control.

I also understand that there is no relevant predicate device to compare with to date based on my research on the FDA site, pertaining to the device i highlighted.

Basically the design and concept of the device is very simialr to a TENS device except for the intended use. We were wondering if anyone knows of an aternative route we could register the device with FDA if not through PMA. Considering the risk classification and device classification it does not seem justified for the device to be subjected to a PMA evaluation, just because its intended use is different. Does anyone have any experience with SECTION 513(F)(2) - Evaluation of Automatic Class III Designation, Guidance for Industry & CDRH Staff.

Thank you all for your advice. And AL, your kind advice is noted.
The issue is for you to show efficacy and not just with anecdotal evidence. You need scientifically sound clinical studies. Do you have any?

As far as I know, the only routes are PMA and 510(k). You can contact someone at FDA Office of Device Evaluation to discuss your application.
 

Al Rosen

Staff member
Super Moderator
#15
Jim Wynne said:
A little :topic: but...

I read a few months ago about a study that compared the effects of fake acupuncture (using collapsing needles that didn't actually penetrate) versus a placebo pill for certain types of pain. The somewhat surprising result was that fake acupuncture proved more effective than fake pills, with a tentative hypothesis being that treatments that are significantly ritualized (i.e., ones that involve doctors actually doing a lot of stuff) seem to be more effective than passive modes of treatment, regardless of whether there is any real intrinsic therapeutic value in the treatment.

It's also interesting to note that a significant number of subjects (in both groups) reported side effects from the fake treatments, and the side effects were the same ones that the subjects were informed of before the study began.
Yes, a lot of it is mind over matter.
 
R

Roland Cooke

#16
I could be wrong on this :rolleyes: , but I am fairly certain that MHRA does not consider smoking cessation devices to be medical devices.

If the device was accepted to be a medical device, I would want to see robust evidence of effectiveness.
 
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