ResApp Health (ASX:RAP) has described as "positive" its recent Pre-Submission Meeting with the US Food and Drug Administration (FDA) regarding its diagnostic mobile software application, ResAppDx.
ResApp Health, founded in 2014, is developing smartphone medical applications for the diagnosis and management of respiratory disease.
During the meeting with the FDA, ResApp received targeted feedback from the agency regarding the proposed US regulatory pathway, clinical study protocols, planned non-clinical evaluations and data requirements.
The company said it can confirm that it will pursue a direct 'de novo' premarket submission for ResAppDx, initially for paediatric use.
"A submission for adult use will be prepared in parallel and will be submitted shortly after the paediatric submission," it said.
The FDA de novo pathway is designed for innovative medical devices where controls provide a reasonable assurance of safety and effectiveness. Thede novo process leads to a Class I or Class II classification and has a 120-day review cycle, compared to a 90-day review period for a 510(k).
The company also confirmed that it will perform clinical studies at one or more US hospitals to provide a key portion of the clinical data required to support both paediatric and adult submissions. The balance of the required data will be gathered from pivotal studies at previously established Australian sites.
According to Dr Tony Keating, CEO and Managing Director of ResApp, “Our Pre-Submission Meeting with the FDA was very productive and we were encouraged by the high level of engagement exhibited by the FDA team. We have obtained the clarity required to optimise our clinical and regulatory pathway and we are on track to reach our announced regulatory milestones.”