I remember a poster on this site some considerable time ago quoted that the new head of the FDA had requested that consideration be given to approving new devices which had been tested and approved in other countries such as Europe Canada and Australia without further testing in USA.
If the app gets approved in USA for children and the adult app is approved in Aus and/or Europe for adults maybe there will be a possibility of no further tests required in USA for adult approval.
Ann: Broker Meets Biotech Presentation, page-8
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