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Private Label Listing Requirements for Medical Devices

QM Becky

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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!


Re: Private Label Listing Requirements

I don't know of any clarification of that requirement, but your interpretation seems reasonable to me.

I'd think further that you would want to have a memo to file documenting in case of FDA inquiry that brand name X belongs to customer A under a private labeling agreement, Y belongs to B, and so forth.

The company for which I work has many private labeling relationships, most of which do not involve brand names as such. I don't think the DLRM Listing requirement for listing of brand names is expected to be a list of customer-company names, so when a private labeled product is identified only by its functional product description and its seller (such as the name of a major imaging OEM), my understanding would be that no entry would be made for brand name.
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