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

GOOD MANUFACTURING PRACTICE (cGMP) US FOOD AND DRUG ADMINISTRATION (FDA)
1

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.

2

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,