The Food and Drugs Administration opened the doors to the US. With this De Novo grant, Sunrise sleep test can be safely added to the US market.
“The DeNovo classification provides a marketing pathway to classify novel medical devices for which general controls alone, or general and special controls, provide reasonable assurance of safety and effectiveness for the intended use, but for which there is no legally marketed predicate device.”
Why a De novo submission?
For a Class II Medical Device classification, the traditional pathway is the 510(k) submission if a substantial equivalence already exists in the FDA database. Sunrise home sleep test uses a unique technology (mandibular movements paired to AI analysis) for the diagnosis of sleep apnea. These are new inputs that don’t have any substantial equivalence.
So Sunrise had to turn towards the De Novo classification, which is similar in complexity to the 510(k) submission.
https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/de-novo-classification-request#:~:text=The De Novo request provides,no legally marketed predicate device.