According to a recent announcement shared with MHW, ResApp Health Limited confirmed that it had a “positive outcome” in its recent Pre-Submission Meeting with the United States Food and Drug Administration (FDA) regarding ResApp’s diagnostic mobile software application, ResAppDx.
During the meeting, we’re told that ResApp received “targeted feedback” from the FDA regarding the proposed US regulatory pathway, clinical study protocols, planned non-clinical evaluations and data requirements.
ResApp can now confirm that it will pursue a direct de novo premarket submission for ResAppDx, initially for pediatric use. A submission for adult use will be prepared in parallel and will be submitted shortly after the pediatric submission. The de novo pathway is designed for innovative medical devices (i.e. those which have no predicate device) where controls provide a reasonable assurance of safety and effectiveness. The de 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).