Is Smoking Cessation Device a Medical Device?

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nafisahbegum

#1
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?
 
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Al Rosen

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Super Moderator
#2
Re: Hello!!!

nafisahbegum said:
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.
 
N

nafisahbegum

#8
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!
 

Al Rosen

Staff member
Super Moderator
#9
The device and regulation, 21cfr882.5890, 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), a far more rigorous and lengthy process then a 510(k) Premarket Notification. You will also need to meet the US FDA Quality System Regulations, 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 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. ISO 13485 is one of them (Quality System).

Your first step is to speak to a Notified Body 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.
 
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