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FDA Codifies Down-Classification For Devices Such As The Apple Watch ECG App

The agency has codified its over-the-counter ECG software class II classification, which means sponsors can continue to benefit from filing for such apps through the less burdensome 510(k) pathway.

A man with an Apple Watch on his wrist also wearing a heart monitor
A man with an Apple Watch on his wrist also wearing a heart monitor • Source: Alamy

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

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