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Looking for some clarification on whether or not a tissue bank would have to register with the FDA as a medical device repackager and relabeler for a combination product. To summarize: we would be sending a packaged finished good medical device to them and then they take their packaged finished good tissue and package them together in a new box and label it. To clarify: my device company is not touching the tissue and the tissue company is not opening the packaged medical device we send to them. It's essentially 2 finished goods (one medical device, one tissue) in a box. My device company would be legal manufacturer.
I believe they would have to register as a medical device repackager and relabeler since they are responsible for the final packaging and labeling. Moreover, the combination product would be registered as a device and, to my knowledge, a facility that packages and labels a device would have to be registered as device repackager and relabeler. However, the tissue bank is pushing back since they believe they only have to register as a device repackager/relabeler.
I hope I'm making sense. Any opinions are welcome. Thank you!