I am new in the device industry and hope someone could provide advice on the following:

the device we have is a TEAS system and its intended use is for smoking cessation. From the device mechanics it seems to be a class iia device, however its intended use is questionable as a disease condition.

Can anyone advice me if this device of ours does comes across as a medical device and thus bounded by the device regulation?

I am new in the device industry and hope someone could provide advice on the following:

the device we have is a TEAS system and its intended use is for smoking cessation. From the device mechanics it seems to be a class iia device, however its intended use is questionable as a disease condition.

Can anyone advice me if this device of ours does comes across as a medical device and thus bounded by the device regulation?Please tell us what "TEAS" stands for.

Well TEAS stands for Transcutaneous electroacupuncture stimulation.

is it for the US?

Yes, we are looking into distribution in EU & US

Well, it appears you are familiar with the following:

http://www.fda.gov/cdrh/devadvice/313.html

and regulation 882.5890

It looks like the device would be a significantly changed design and probably require a 510k submission, but at this stage the people to ask (for the US market) are at the CDRH.

See http://www.fda.gov/cdrh/contacts.html

and http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfDSMA/dsma-form.cfm

Hello there,

Thank you for the advice.
Have a good day!

I must say this site is really informative, am glad that i have come upon it!

I have a query on ISO13485. I understand that ISO13485 is a standard stipulating requirements specific to the medical device industry.

If the manufacturer is already ISO9001 Certified, is it a requirement to get an ISO13485 certification?

Is it possible only to account for the differences between the 2 standards and comply with the additional requirements of ISO13485 without going through a certification process?

Thanks in advance!

The device and regulation, 21cfr882.5890 (http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=882.5890), that atetsade refered to was a device indicated for pain. The device you are proposing would have a new indication for use and as such would require a Premarket Approval (PMA), (http://www.fda.gov/cdrh/devadvice/pma/) a far more rigorous and lengthy process then a 510(k) Premarket Notification (http://www.fda.gov/cdrh/devadvice/314.html). You will also need to meet the US FDA Quality System Regulations, (http://www.fda.gov/cdrh/devadvice/32.html) which is slightly different than ISO 13485.

As far as the EU and ISO 13485 is concerned, you do not need to be certified to it, but you do need to be assessed to all the requirements in the Medical Device Directive, 93/42/EEC (http://elsmar.com/Forums/attachment.php?attachmentid=3000) including the Essential Requirements in Annex I. One of the easiest ways to do this is to show compliance through the use of the appropriate Harmonised Standards (http://ec.europa.eu/enterprise/newapproach/standardization/harmstds/reflist/meddevic.html). ISO 13485 is one of them (Quality System).

Your first step is to speak to a Notified Body (http://ec.europa.eu/enterprise/newapproach/legislation/nb/notified_bodies.htm) in the EU and determine what you will need to do.

Another piece of advice I have is to always verify the advice you receive from anyone. There may be other aspects someone else may not be aware of.

That's true, Al. Thanks for the correction.

Does the device actually help people stop smoking?

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.

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.

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.

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 (http://www.fda.gov/cdrh/organiz.html#ODE) to discuss your application.

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.

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.