The US Food and Drug Administration has clarified its decision to classify over-the-counter electrocardiograph (ECG) software as class II devices with special controls. The move comes more than three years after the Apple Inc. Watch controversially received a de novo authorization for an ECG app.
In a 18 January Federal Register notice, the FDA announced a final order that codifies the agency’s decision to classify OTC ECG software as class II devices with special controls