Kyle Faget Authors Article on Considerations for Mobile Health Technology Developers

Foley & Lardner LLP Partner Kyle Faget authored the article, “Considerations for Mobile Health Technology Developers: Part 1,” published by pharmaphorum, about the U.S. Food and Drug Administration (FDA)’s common approach to regulating mHealth products, general wellness devices, and mobile medical applications.

Faget says, “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 (FDA) regulation as a medical device.  If so, developers must develop and execute on a regulatory strategy.”

Part 2 of this series will be devoted to clinical decision support (CDS) software.