A
Hi everyone,
I represent a new company that is working toward establishment a PL brand of home test kits (drug tests). If my research is correct, then this falls under the category of Class I - 510(K) Exempt.
With that said, my question is based on the following:
If we are outsourcing the product and having a manufacturer from overseas create, apply label, and package the product, and then shipped to the states where we will simply distribute. Do we have to register with the FDA and pay the fee of ($4.6k), or is there another route that exists? We really want to address any necessary documents in order to avoid any conflicts with US Customs.
Any advice is appreciated, thank you very much.
- aadel
I represent a new company that is working toward establishment a PL brand of home test kits (drug tests). If my research is correct, then this falls under the category of Class I - 510(K) Exempt.
With that said, my question is based on the following:
If we are outsourcing the product and having a manufacturer from overseas create, apply label, and package the product, and then shipped to the states where we will simply distribute. Do we have to register with the FDA and pay the fee of ($4.6k), or is there another route that exists? We really want to address any necessary documents in order to avoid any conflicts with US Customs.
Any advice is appreciated, thank you very much.
- aadel