What Does the Apple Watch Series 4’s FDA Certification Actually Mean?

TheApple Watch Series 4is the first ever smartwatch that is capable of delivering‘FDA-certified’ECG (Electrocardiogram) test results, thanks to a new electrical heart rate sensor which can monitor the heart rhythm and detect anomalies such as atrial fibrillation (AFib).

But there are a few conditions associated with the FDA certification awarded to the Apple Watch Series 4’s ECG capabilities that you might not be aware of. First of all, the smartwatch’s ability to measure the ECG and irregular heart rhythm hasonly been granted a ‘clearance’, andnot an ‘approval’from the US FDA.

There is a major difference between ‘FDA-Approved’ and ‘FDA-Cleared’. The approval is granted only to Class III devices such as a pacemaker, which has a higher risk but also delivers greater benefits. As for the Apple Watch Series 4,it falls under the category of Class II deviceswhich only receive an‘FDA clearance’, a tag associated with devices which pose a lower risk and offer generic benefits.

FDA concludes that this device should be classified into Class II. This order, therefore, classifies the ECG. App, and substantially equivalent devices of this generic type, into Class II under the generic name electrocardiograph software for over-the-counter use.

Moreover, the FDA has prescribed certain norms for Class II devices such as the Apple Watch regarding their accuracy, intended usage, interpretation of results and a few other key parameters which are mentioned below:

The US FDA identifies the Apple Watch Series 4 as a Class II device which canprovide reasonable assurance of the safety and effectiveness.However, the FDA clearance is not an easy feat to achieve, because Apple’s smartwatch had to pass a number of quality control tests such as efficacy at obtaining ECG of sufficient quality, sensitivity, software verification and validation, non-clinical performance testing, etc.

Nadeem Sarwar

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