On July 29, the US Food and Drug Administration released a guidance on multiple-function device products. The guidance document explains the agency’s regulatory approach and policy for all multiple function device products. Specifically, the guidance clarifies when and how the US FDA intends to assess the impact of “other functions” that are not the subject of a pre-market review on the safety and effectiveness of a device function that
is subject to FDA review. The purpose of this guidance is to identify the principles, pre-market review practices, and policies for the US FDA’s regulatory assessment of such products, and to provide examples of the application of these policies.
Commenting on the same, Kamilla Kan, medical device analyst, GlobalData, said, “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 centralised public servers to process data will be forced to use a more decentralised approach with better data encryption.”