FDA Product Code QFT: Digital Therapeutic Software For Attention Deficit Hyperactivity Disorder
A Digital Therapy Device For Attention Deficit Hyperactivity Disorder (adhd) Is A Software Intended To Provide Therapy For Adhd Or Any Of Its Individual Symptoms As An Adjunct To Clinician Supervised Treatment.
Leading manufacturers include Akili Interactive Labs, Inc. and Lumos Labs, Inc..
FDA 510(k) Cleared Digital Therapeutic Software For Attention Deficit Hyperactivity Disorder Devices (Product Code QFT)
About Product Code QFT - Regulatory Context
510(k) Submission Activity
4 total 510(k) submissions under product code QFT since 2020, with 3 receiving FDA clearance (average review time: 175 days).
Submission volume has increased in recent years - 2 submissions in the last 24 months compared to 1 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under QFT have taken an average of 210 days to reach a decision - up from 140 days historically. Manufacturers should account for longer review timelines in current project planning.
QFT devices are reviewed by the Neurology panel. Browse all Neurology devices →