ResApp Health Limited provided the update on the Company's recent meeting with the United States (US) Food and Drug Administration (FDA) regarding the clearance of its mobile medical application SleepCheck for use in the US. SleepCheck is ResApp's easy to use, direct-to-consumer mobile medical application that uses clinically accurate algorithms to assess a person's risk of obstructive sleep apnoea by analysing breathing and snoring sounds during sleep. It requires no accessories or hardware other than a smartphone to make an assessment. The company advises that positive engagement with the FDA has defined a clear path towards gaining regulatory approval. ResApp will pursue a 510(k)ii regulatory pathway for SleepCheck, initially as a prescription only (Rx only) device. The 510(k) approach is the fastest route to market and leverages a prior 510(k) clearance granted for a predicate device. The company will commence a human factors study in the US at the beginning of third quarter of fiscal 2021. A human factors study employs representative users to assess the product user interface design. Human factors studies only require a minimum of 15 representative users and are shorter and considerably cheaper than clinical studies. ResApp has successfully carried out similar studies for SleepCheck in Australia. The lodgement of a 510(k) submission is expected to occur by the end of third quarter fiscal 2021, with a decision from the FDA anticipated 90 days thereafter. Should the company be successful in attaining 510(k) clearance, SleepCheck Rx would be made available to consumers through a direct-to-consumer telemedicine visit. Healthcare providers would conduct a virtual consultation and prescribe SleepCheck to potential sleep apnoea sufferers, providing a specific code allowing them to download SleepCheck Rx from the Apple or Google Play store. ResApp also received advice on the requirements to progress an over-the-counter (OTC) approval. The FDA stated that this process would entail additional clinical and human factors studies due to the lack of an FDA cleared OTC predicate device. To support a potential OTC approval, ResApp will commence a US sleep laboratory-based clinical study during fourth quarter of fiscal 2021, in parallel with the 510(k) prescription only process. FDA clearance would unlock a substantial market opportunity for ResApp. It is estimated that 42m American adults suffer from sleep disordered breathing (SDB)iii, three in ten men and almost one in five women have sleep apnoeaiv. It is further estimated that 75% of SDB cases remain undiagnosedv.