ResApp completes successful Pre-Submission meeting with the US FDA
ResApp Health Limited , announced 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.
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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 paediatric use. A submission for adult use will be prepared in parallel and will be submitted shortly after the paediatric submission.
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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).