510(k) filing for GSM (Global System for Mobile Communication) technology?

[kisxena]

Hi:

Just thought I'd ask first before spendings hours trying to find the answer, which I probably won't in regards to my question.

We currently have a monitoring device which uses CDMA technology and are 510(k) approved. We may be putting this device in Europe, so we would need to use GSM technology.

My question is, would we have to file a new 510(k) for the GSM technology?

Any advise is appreciated.

Thanks

 

[MIREGMGR]

Re: 510(k) filing for GSM technology?

Would the GSM product-version be sold in the US?

If no, a 510(k) for that product-version would seem to be irrelevant. You would of course have to have the appropriate 13485/MDD/CE ducks in a row regarding EU regulation. If in addition to the MDD there is an RF-devices or telecommunications Directive, you'd have to double-check as well that its requirements didn't conflict with your intentions and requirements.

If yes, perhaps you could file a Special, given that the RF-link technology difference would be (in medical device terms) not fundamental, and presumably little or nothing would change about the product other than that RF-link approach.

 

[kisxena]

Re: 510(k) filing for GSM technology?

Thanks for the information.

No, we don't sell our device. It is prescribed to patients and returned upon completion of their monitoring cycle.

I will check the RF-devices and telecommunications directive to see if this will constitute in filing a 510(k).

 

[Ajit Basrur]

Re: 510(k) filing for GSM technology?

If there is no marketing in US, a 510 (k) is not required.

 

[Weiner Dog]

Re: 510(k) filing for GSM technology?

Ajit Basrur is correct. Just because a medical device is manufactured in the US, it does not need a 510(k) if not distributed in the US. Of course, you have to abide by the GMP's of the country it is being distributed & may need an export certificate (from the FDA, depending upon the country).

 

[Al Rosen]

Re: 510(k) filing for GSM technology?

Thanks for the information.

No, we don't sell our device. It is prescribed to patients and returned upon completion of their monitoring cycle.

I will check the RF-devices and telecommunications directive to see if this will constitute in filing a 510(k).

Sales is not the issue. If you are making it available in the US, you will need to evaluate whether a 510(k) is necessary and then which type.

 

[MIREGMGR]

Re: 510(k) filing for GSM technology?

I would have thought it would have been obvious that when I used the word "sold", I actually was referring to marketing and/or authorized usage.

 

[Al Rosen]

Re: 510(k) filing for GSM technology?

I would have thought it would have been obvious that when I used the word "sold", I actually was referring to marketing and/or authorized usage.

You can never assume here.

 

[Nissim Shaked]

A very good idea will be to remove all the FDA registration number and its related information from all of your new devise labeling, and in your internal QA system to restrict it from being able to be distributed at the USA.

 

[venkatesan]

Hi:

Just thought I'd ask first before spendings hours trying to find the answer, which I probably won't in regards to my question.

We currently have a monitoring device which uses CDMA technology and are 510(k) approved. We may be putting this device in Europe, so we would need to use GSM technology.

My question is, would we have to file a new 510(k) for the GSM technology?

Any advise is appreciated.

Thanks

Sir

I dont know atleast what is meaning of that GSM, what for we have to use please let me know.