New model for existing Class I Device Listing (510K exempt)

[ganglai]

Hi all,

We have a device listing for a class I medical device under our company's establishment registration.

If we have a new model developed for the same product code listed under the device listing, what should I do to enable us to sell this new model to the US Market.

I am new to this FDA Device Listing. All help is appreciated.

Thank you.

 

[sreenu927]

Re: New model for existing Class I Device Listing (510K exampt)

Assume the new model was developed following 21 CFR 820 applicable sections. You update your listing information to add the new model by entering into your FURLS account.

Regards,
Sreenu

 

[Ronen E]

Re: New model for existing Class I Device Listing (510K exampt)

Hi all,

We have a device listing for a class I medical device under our company's establishment registration.

If we have a new model developed for the same product code listed under the device listing, what should I do to enable us to sell this new model to the US Market.

I am new to this FDA Device Listing. All help is appreciated.

Thank you.

Is the new model substantially different from the device you have cleared, or is it just a variant?

 

[ganglai]

Re: New model for existing Class I Device Listing (510K exampt)

The new model is quite similar to previous cleared models.

 

[Ronen E]

Re: New model for existing Class I Device Listing (510K exampt)

The new model is quite similar to previous cleared models.

Then you can quite treat it as if it was the same device...

 

[ganglai]

Re: New model for existing Class I Device Listing (510K exampt)

Then you can quite treat it as if it was the same device...

Thanks Ronen.
This new model will have a new model number for itself.
Will any cost incur for adding this new model in the FURLS account? How will we be informed by FDA this new model can be sold to the US market?

 

[sreenu927]

Once you perform listing activity in FURLS, immediately (or in a day/two), the FDA site will be updated with your new listing information. Once it is listed, you can start selling (or import) the product in US.
FDA won't inform you about this. Once you complete the listing, when importing, make sure you provide the device listing number and establishment registration number in your customs documentation.

Regards,
Sreenu

 

[ganglai]

Thanks Sreenu. All clear.

 

[QualityDean]

We have a similar issue, but I'm wondering about the "30 day" listing in FURLS before you can sell the device. If we already have a Device FDA Registration # and the new medical kit is a simple variation, can I just add the new device to the same Registration # simply by adding the new device to proprietary names and not have to wait 30 days to sell the variation product? Our device is Class I, exempt from 510k.