FDA Product Code QDA: Electrocardiograph Software For Over-the-counter Use
An Electrocardiograph Software Device For Over-the-counter Use Creates, Analyzes, And Displays Electrocardiograph Data, And Can Provide Information For Identifying Cardiac Arrhythmias. This Device Is Not Intended To Provide A Diagnosis.
Leading manufacturers include Samsung Electronics Co., Ltd., Withings and Whoop., Inc..
FDA 510(k) Cleared Electrocardiograph Software For Over-the-counter Use Devices (Product Code QDA)
About Product Code QDA - Regulatory Context
510(k) Submission Activity
9 total 510(k) submissions under product code QDA since 2018, with 8 receiving FDA clearance (average review time: 160 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 QDA have taken an average of 249 days to reach a decision - up from 116 days historically. Manufacturers should account for longer review timelines in current project planning.
QDA devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →