Regulatory Open Forum

Hello friends

Is there a way to use existing product code that does not have any products approved/cleared under it? I just found a product code that fits the product perfectly but found no products with this product code to check options for comparison. Frustrating a bit :) Though maybe you will have creative ideas. 

Thank you

Hi Ella,

Probably would need to know the Product Code (if speaking about US FDA) to provide further comment.  This can exist though it is fairly rare.  The other thought is check all of databases, because there might be a Product Code designated under De Novo and there has not been any products cleared through the 510(k) process - meaning there has only been one product which has gone through the De Novo process.

Hello friends

Is there a way to use existing product code that does not have any products approved/cleared under it? I just found a product code that fits the product perfectly but found no products with this product code to check options for comparison. Frustrating a bit :) Though maybe you will have creative ideas. 

Thank you

Hi Richard

The product code is HRL and I haven't found it in any database.

Thanks

Ella

Hi Ella,

Probably would need to know the Product Code (if speaking about US FDA) to provide further comment.  This can exist though it is fairly rare.  The other thought is check all of databases, because there might be a Product Code designated under De Novo and there has not been any products cleared through the 510(k) process - meaning there has only been one product which has gone through the De Novo process.

Hello friends

Is there a way to use existing product code that does not have any products approved/cleared under it? I just found a product code that fits the product perfectly but found no products with this product code to check options for comparison. Frustrating a bit :) Though maybe you will have creative ideas. 

Thank you

I think Ella based on the description and code, this is probably a "pre-amendment" device code meaning a product which was available prior to 1976 though has not really been used since then.  Thus there is not any registered 510(k)s.  This product type has been around for a long time, so I would guess it is one of those pre-amendment devices which got a Product Code in 1976 and then nothing happened since that time, i.e. no change in technology.

Hi Richard

The product code is HRL and I haven't found it in any database.

Thanks

Ella

Hi Ella,

Probably would need to know the Product Code (if speaking about US FDA) to provide further comment.  This can exist though it is fairly rare.  The other thought is check all of databases, because there might be a Product Code designated under De Novo and there has not been any products cleared through the 510(k) process - meaning there has only been one product which has gone through the De Novo process.

Hello friends

Is there a way to use existing product code that does not have any products approved/cleared under it? I just found a product code that fits the product perfectly but found no products with this product code to check options for comparison. Frustrating a bit :) Though maybe you will have creative ideas. 

Thank you