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)