Neurotech International (ASX: NTI) has filed a pre-submission package with the United States FDA for its neurofeedback device for children on the autism spectrum, Mente Autism.
The company said it has requested a meeting with the FDA to work cooperatively on the regulatory and clinical plan to support FDA clearance of Mente Autism. It added the FDA’s Center for Devices and Radiological Health has confirmed receipt of the submission and Neurotech management expects the meeting to take place in the third quarter of 2017.
The pre-submission is a written request for feedback from the FDA, provided either as a formal written response or a meeting in which the feedback is documented. It is intended to allow applicants the opportunity to obtain targeted FDA feedback regarding product development, including planned non-clinical evaluations, proposed clinical study protocols or data requirements, prior to making a submission to the FDA.
Neurotech said it currently plans to market Mente Autism in the US as a Class II regulated device, supported by clinical data. An independent, randomised, double blind clinical study is currently being conducted by the Carrick Institute in Florida.
“Filing the pre-submission package is a major step towards obtaining FDA clearance for Mente Autism, our innovative home-based neurofeedback therapy for children on the autism spectrum. The planned meeting with the FDA will provide us with feedback on our clinical and regulatory plan as well as clarify the requirements for us to market our technology in the US market,” said CEO Wolfgang Storf.