Private Labeling a Class II device to be used with our device

B-Kabitz

Registered
Need advice here. We are considering selling a private labeled class II device to Doctors to be used with our own cleared Class II device; not as a kit, and not supplied with our cleared device, but supplied separately. Two Questions: 1. We do not intend on suppling any labeling at all, except the OEM's IFU, we offer no training and no literature at all, just offering the private labeled device as-is; can we do that per FDA regulations (I have not found anything specific)? 2. Would the FDA have a problem with this approach because we "Intended" the private labeled device to be used with our device as a kit?
 

Parul Chansoria

Regulatory and Quality Expert
Hi @B-Kabitz here is some information to address your 2 questions:

1. Even if you are selling the private labelled product (as is) for use with your product, you would have to check to see if the private labeled product is compatible with your cleared product. There should be some evidence to support compatibility and safety and efficacy when used together. It is fine to leverage this information from the OEM, but the information should exist, else there is no evidence that the privately labeled product will work well with the cleared product and continue to achieve the intended use and performance that it is meant to.

2. In the grand scheme of things, one needs to identify who is the "legal manufacturer" of the privately labeled product, that is the one will take accountability of labelling, testing, QSR, MDR reporting, and continued compliance of the privately labelled product. Since you are the legal manufacturer of the cleared product and you are selling the privately labeled products to "your customers" and "intend" that the privately labeled product should be used with "your cleared product", you will have to conduct a "suitability evaluation" where you review and determine that the privately labeled product is in fact suitable to be used with your product. This suitability evaluation should include a review of FDA clearances, labeling, indication for use for which the privately labeled product is cleared and ensuring that the use with your cleared product does not make it an "off label" use, compatibility, etc.

Hope this helps.
Best,
Parul Chansoria
 
Top Bottom