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.