FDA multiple-function device products update particularly affects telehealth, says GlobalData

Following Food and Drug Administration (FDA) announcement that guidelines on multiple-function devices were finalized;

Kamilla Kan, Medical Device Analyst at GlobalData, a leading data and analytics company, offers her view on the recent news:

“In its latest guidance update, the FDA’s advise that manufacturers should review whether the other functions of a medical device impact the safety and performance of the device functionality will particularly affect the telehealth market, especially mobile health applications. Manufacturers of multiple function products such as these will need to spend additional time and money to assess and document functions, slowing down development time.

“With the number of people using telehealth services such as mobile health applications increasing every month due to the COVID-19 pandemic, this approach might be particularly beneficial to ensure proper regulation is maintained. As a result of the new regulations, device manufacturers will implement separation and support segregation of device functions that pose potential risk –  for instance, numerous mobile health applications that use centralized public servers to process data will be forced to use a more decentralized approach with better data encryption.”

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