Q
Hi Everyone,
I'm completing my annual listing/registration review/certification and it occured to me I may or may not be doing this correctly and would appreciate any recommendations or experiences other folks may have had and are willing to share.
We are a US based device manufacturer. We have all Class II and Class I devices and hold 510(k) clearances for all of them (as required). Our products are on the US market under our own brand name. We have recently began private labeling some of our products for one of the bigger players in the device market. It is still the same product, same clearance, just a different brand, and we are listed as the manufacturer.
My question is: In the registration and listing database, when I list my product, under the category for "Proprietary Name" or Brand Name, should I be listing the brand name of the private label?
I feel like I should be, as the other company is receiving a finished device and is strictly a distributor. As a distributor, they would not list this device so it's technically not listed anywhere under that brand name.
I didn't see anything on the FDA website or CFR references that specifically addresses this question, except to say [sic] "list all brand names".
Any thoughts?
Thanks in advance!
I'm completing my annual listing/registration review/certification and it occured to me I may or may not be doing this correctly and would appreciate any recommendations or experiences other folks may have had and are willing to share.
We are a US based device manufacturer. We have all Class II and Class I devices and hold 510(k) clearances for all of them (as required). Our products are on the US market under our own brand name. We have recently began private labeling some of our products for one of the bigger players in the device market. It is still the same product, same clearance, just a different brand, and we are listed as the manufacturer.
My question is: In the registration and listing database, when I list my product, under the category for "Proprietary Name" or Brand Name, should I be listing the brand name of the private label?
I feel like I should be, as the other company is receiving a finished device and is strictly a distributor. As a distributor, they would not list this device so it's technically not listed anywhere under that brand name.
I didn't see anything on the FDA website or CFR references that specifically addresses this question, except to say [sic] "list all brand names".
Any thoughts?
Thanks in advance!