pharmaphorum September 28, 2022
In Part 1 of this series, general wellness devices and mobile medical applications (MMAs) will be considered. Part 2 of this series will be devoted to clinical decision support (CDS) software.
The FDA’s General Approach to Regulating mHealth Products
Although mHealth has been gaining in popularity for at least the past decade, before commercializing their mHealth products, developers must determine whether the product is subject to U.S. Food and Drug Administration (FDA) regulation as a medical device. If so, developers must develop and execute on a regulatory strategy.
Determining whether a product is a medical device subject to FDA regulation necessarily begins with understanding the FDA regulatory definition of ‘medical device’. A medical device is statutorily defined as an instrument,...
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