M
We are considering a product line of topical anesthetic with 20% benzocaine for dental use. Our company is ISO 13485 and FDA registered for medical devices but we have never carried a product like this so I am wondering where to start. I searched the FDA database for the brand name and even the supplier name (there are two brands, one spray another is swabbed on). I also searched by type of product and cannot find a product code, classification nor the suppliers names.
This is a popular item and I want to get it registered as well as start a technical file so I can add them to our scope next audit.
Is there not enough of benzocaine in it to concern the FDA? It is used in the mouth and I am sure there has to be a listing somewhere. I called the suppliers and they are not wanting to give me the information-I think my inquiry scared them.
Please help!
Medic
This is a popular item and I want to get it registered as well as start a technical file so I can add them to our scope next audit.
Is there not enough of benzocaine in it to concern the FDA? It is used in the mouth and I am sure there has to be a listing somewhere. I called the suppliers and they are not wanting to give me the information-I think my inquiry scared them.
Please help!
Medic