FDA Product Code QPF: Pediatric Autism Spectrum Disorder Diagnosis Aid
A Pediatric Autism Spectrum Disorder Diagnosis Aid Is A Prescription Device That Is Intended For Use As An Aid In The Diagnosis Of Autism Spectrum Disorder In Pediatric Patients.
Leading manufacturers include Cognoa, Inc., Earlitec Diagnostics, Inc. and Earlitec Diagnostics.
FDA 510(k) Cleared Pediatric Autism Spectrum Disorder Diagnosis Aid Devices (Product Code QPF)
About Product Code QPF - Regulatory Context
510(k) Submission Activity
6 total 510(k) submissions under product code QPF since 2021, with 5 receiving FDA clearance (average review time: 155 days).
Submission volume has increased in recent years - 3 submissions in the last 24 months compared to 2 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under QPF have taken an average of 132 days to reach a decision - down from 177 days historically, suggesting improved FDA processing for this classification.
QPF devices are reviewed by the Neurology panel. Browse all Neurology devices →