Hi Ya'll!

Quick question - For a US company private labeling a FDA class II device - isn't it required that this OEM company obtain a 510(k) for their private labelled product even if the source manufacturer possesses 510(k) clearance for the same device with different labeling? What is your take on this?

Senna

Hi Ya'll!

Quick question - For a US company private labeling a FDA class II device - isn't it required that this OEM company obtain a 510(k) for their private labelled product even if the source manufacturer possesses 510(k) clearance for the same device with different labeling? What is your take on this?

Senna
The 510(k) is not required if the device is being distributed under a "Private Label", i.e., a preamendment device or device with a valid 510(k) which is being placed into commercial distribution for the first time by a distributor under their own name or a repackager who places their own name on a device provided no changes are made to the device or its indications for use, and it is not further processed, e.g.. sterilized.

See:
PREMARKET NOTIFICATION 510(k):REGULATORY REQUIREMENTS FOR MEDICAL DEVICES (http://www.fda.gov/cdrh/manual/510kprt1.html#overview)

Hi Ya'll!

Quick question - For a US company private labeling a FDA class II device - isn't it required that this OEM company obtain a 510(k) for their private labelled product even if the source manufacturer possesses 510(k) clearance for the same device with different labeling? What is your take on this?

Senna

Hi Senna,

There are very few Class II devices that would require concurrence on a 510(K) to transfer production to an OEM. Generally, as long as the OEM's labeling doesn't change the general intended use of the device, or its claims, it will not need to apply for clearance. The company that contracts the OEM will be expected to manage it through its purchasing controls processes.

FDA doesn't approve labeling for 510(K) devices. So, the labeling that's included in the submission generally consists of the basic elements: brand name, claims, warnings, etc.

The person responsible for regulatory affairs at the company that owns the cleared device should be monitoring and approving the labeling that the OEM ultimately places on the product. The responsibility for the safety and effectiveness of the device will remain on the owner - not the contractor. So, the 510(K) owner will need to perform the necessary supplier qualification (ie supplier audit) and transfer of production, including process validation, in order to consider the OEM "qualified".

What kind of device is it?

Chris Ford