Maybe good timeline guidance for EMU.
NAN's clearance took 340 days from submission on 1 May 2024. This is close to the average , as below:
"The average time for De Novo classification requests, according to a study of FDA data, is around 338 days (median = 309 days), significantly longer than the average 510(k) review time of 150 days"
The estimate for the validation trial for EMU is 6-12 months from March 2025 implies completion between Sept 2025 and Mar 2026.
Based on the average de novo process of 10 months, we can expect commercialisation between Jul 2026 and Jan 2027.
Ann: First Responder Scanner in Successful Aeromedical Testing, page-9
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