On December 7, 2017, the US Food and Drug Administration (FDA) announced several digital health policy documents designed to “encourage innovation” and “bring efficiency and modernization” to the agency’s regulation of digital health products. The three documents include two draft and one final guidance which address, in part, the important changes made by Section 3060 of the 21st Century Cures Act (Cures Act) to the medical device provisions of the Federal, Food, Drug, and Cosmetic Act (FDCA), which we previously summarized, that expressly excluded from the definition of medical device five distinct categories of software or digital health products. FDA Commissioner Dr. Scott Gottlieb emphasized that these documents collectively “offer additional clarity about where the FDA sees its role in digital health, and importantly, where we don’t see a need for FDA involvement.”

To read the full advisory click here.