On Tuesday, September 11th, FDA granted two de novo classification requests for mobile medical applications to be used with the Apple Watch.
The first app, referred to as the ECG app, displays electrocardiograph (ECG) data to detect atrial fibrillation (AFib). According to the recent classification order, “the ECG app is a software-only mobile medical application intended for use with the Apple Watch to create, record, store, transfer, and display a single channel electrocardiogram similar to a Lead I ECG. The ECG app determines the presence of atrial fibrillation or sinus rhythm on a classifiable waveform.” This device was classified into Class II and is not intended for use in people under 22 years old.
The second app, called the Irregular Rhythm Notification Feature, is also a software-only mobile medical application that uses pulse-rate data to notify users of potential AFib episodes. The classification order describes the feature as a tool that “analyzes pulse rate data to identify episodes of irregular heart rhythms suggestive of atrial fibrillation and provides a notification to the user […] [the feature] is not intended to provide a notification on every episode of irregular rhythm suggestive of AFib and the absence of a notification is not intended to indicate no disease process is present.” This device was also classified into Class II and is not intended for people under 22 years old or for individuals previously diagnosed with AFib.
FDA recently released a statement on Agency efforts to promote digital health innovation. In the last few years, the Agency has taken steps to encourage the development of emerging technologies in digital health.
To aid in this process, the FDA has proposed the creation of a “Center of Excellence for Digital Health.” According to the joint statement by FDA Commissioner Scott Gottlieb, M.D. and CDRH Director Jeff Shuren, M.D., J.D., “this Center of Excellence would help establish more efficient regulatory paradigms, consider building new capacity to evaluate and recognize third-party certifiers, and support a cybersecurity unit to complement the advances in software-based devices.”
FDA’s recent approvals and clearances of digital health products, including the two AFib mobile medical apps, give users more information and control over their health.
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