Kyle Faget Authors Second Article on Considerations for Mobile Health Technology Developers

Foley & Lardner LLP Partner Kyle Faget authored the article,  “Considerations for Mobile Health Technology Developers: Part 2,” published by pharmaphorum, about the U.S. Food and Drug Administration (FDA)’s recently issued guidance for industry and FDA staff clinical decision support software (CDS).

In the final guidance, the FDA clarifies that certain types of CDS software functions are excluded from the definition of a medical device when such products meet all four of certain criteria. Faget explains these four criteria in detail, saying that the guidance “includes several examples of device and non-device CDS, which should be carefully reviewed by developers when designing and implementing an FDA regulatory strategy.”

Part 1 of this series was devoted to the FDA’s general approach to regulating mHealth products, general wellness devices, and mobile medical applications.