chaddy - it depends on how long this process takes (as included in the Quarterly on 28 Jan):
"In the US, EMVision is seeking Non-Significant Risk (“NSR” medical device study designation to expedite the start-up process. A central Institutional Review Board (IRB) is engaged to assess the study for NSR and ethics approval"
My reading of the FDA guideline is that it should be quite straight forward getting the NSR designation - which will streamline the whole process. See guideline here: https://www.fda.gov/media/75459/download
But also depends on new administration getting its act together - as per this:
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medical device study designation to expedite the start-up process. A central Institutional Review Board (IRB) is engaged to assess the study for NSR and ethics approval"
(20min delay)