Mar 17 2016
ResApp Health Limited, announced today a positive outcome from 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 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).
The Company also confirms that it will perform pivotal clinical studies at one or more US hospitals to provide a key portion of the clinical data required to support both pediatric and adult submissions. The balance of the required data will be gathered from pivotal studies at previously established Australian sites.
Dr Tony Keating, CEO and Managing Director of ResApp, said:
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 optimize our clinical and regulatory pathway and we are on track to reach our announced regulatory milestones.
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