03/01/2024
VRAT™ Advances to Substantive Review Stage in FDA 510(k) Application Process Irvine, CA – August 21, 2023
We are pleased to announce a significant milestone in the regulatory journey of VRAT™, as it has now entered the Substantive Review phase of the U.S. Food and Drug Administration’s (FDA) 510(k) application process for medical devices. The Virtual Reality Attention Tracker (VRAT™) is the first immersive VR-based digital assessment tool that combines cognitive and biometric data evaluation to improve the assessment of children and adolescents suspected of having ADHD. This advancement signifies that VRAT's application has successfully passed the initial Administrative Review (RTA Review) phase, confirming that the 510(k) submission package is comprehensive and includes all necessary items as per the FDA’s 510(k) checklist.
The commencement of the Substantive Review phase marks a critical step in the FDA’s thorough examination of VRAT’s application. During this phase, the FDA will conduct an in-depth analysis of all aspects of the submission package. This review is pivotal, as the FDA may request additional information or justification to ensure the application meets all regulatory standards and requirements.
The conclusion of the Substantive Review will lead to a final decision by the FDA regarding the approval status of VRAT™. We are committed to cooperating fully with the FDA throughout this process and are optimistic about the future prospects of VRAT™ in enhancing healthcare outcomes.
