AI devices with FDA product code QDB — Photoplethysmograph Analysis Software For Over-The-Counter Use

Product code QDB (“Photoplethysmograph Analysis Software For Over-The-Counter Use” in openFDA) covers 3 devices on the FDA AI-enabled list, from 1 company. Most are reviewed by the Cardiovascular panel (3). The most recent decision was Irregular Rhythm Notification Feature (IRNF) on July 21, 2023.