Apple Sets the Stage for FDA Regulation on Two Types of AFib Mobile Medical Apps

Regulatory NewsRegulatory News | 12 September 2018 |  By 

The US Food and Drug Administration (FDA) granted two de novo classification requests on Tuesday on applications to be used with the Apple Watch for identifying irregular heart rhythms.
Both devices are software-only mobile medical applications for over-the-counter use designed to aid in the process of determining risk of atrial fibrillation (AFib), though they are designed to help Apple Watch users supplement traditional methods of diagnosis or treatment, rather than replace such methods. 

One is intended for the display of electrocardiograph data, whereas the other is designed to notify users of AFib-suggestive episodes based on users’ pulse rate data. Neither are intended for use by patients under the age of 22, according to the letters FDA issued to the tech giant.
Apple saw a quick turnaround with the de novo classification requests submitted to FDA on 9 and 12 August, with news of the clearances coinciding with its unveiling of the Apple Watch Series 4. The world’s most valuable company is one of the select few participants in a pilot program operating under the agency’s Center for Devices and Radiological Health (CDRH) to advance a shift to support innovation in the digital health space. The program will be opened up to other companies once it becomes fully operational by year’s end.
Special controls were identified to mitigate the potential risks to patient safety, such as false negatives or false positives, in conjunction with FDA’s conclusions that both of Apple’s mobile application types should be regulated as Class II medical devices. These relate to clinical performance and human factors testing, labeling and software verifications, among others.
“FDA worked closely with the company as they developed and tested these software products, which may help millions of users identify health concerns more quickly,” FDA Commissioner Scott Gottlieb and CDRH Director Jeff Shuren said in a joint statement, issued Wednesday. “Health care products on ubiquitous devices, like smart watches, may help users seek treatment earlier and will truly empower them with more information about their health.”
Electrocardiograph software for over-the-counter use
Irregular Rhythm Notification Feature


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