It comes down to old data (but that's OK) and have they done enough research.
For approval as a device - they probably have as they have shown no harm.
Other products have got through easily without trial, Spray on Skin (ReCell) is an example that comes to mind.
It is a lot easier to get a device through, than a drug.
It comes down to old data (but that's OK) and have they done...
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