A
Our company is considering a Private Labeled - 510K Class II devicefrom an OEM. Per the OEM, it is preamendment device.
The OEM would place our Private Label on the device and ships it to our Mexico facility. From the Mexico location the product would be shipped into the USA to our customers. Also, some product will be repackaged in smaller quantities (example: A 500 unit box repackaged as 100 units per box.)
Since the OEM does not have a 510K, would we need a 510K?
How should this be registered with the FDA as a repackager or relabler?
The OEM would place our Private Label on the device and ships it to our Mexico facility. From the Mexico location the product would be shipped into the USA to our customers. Also, some product will be repackaged in smaller quantities (example: A 500 unit box repackaged as 100 units per box.)
Since the OEM does not have a 510K, would we need a 510K?
How should this be registered with the FDA as a repackager or relabler?
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