The press release issued by the U.S. Food and Drug Administration (FDA), which operates under the Department of Health and Human Services (HHS), on July 19, 2011, signaled the beginning of its regulatory process, this time concerning “mobile medical apps.” The announcement made it plain that such regulation certainly fell under its jurisdiction, as if declaring it made it so: “The use of mobile medical apps on smart phones and tablets is revolutionizing health care delivery,” according to Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health. “Our draft approach calls for oversight of only those mobile medical apps that present the greatest risk to patients when they don’t work as intended.”
Beginning its existence in 1927 as the Food, Drug, and Insecticide organization (becoming the Food and Drug Administration in 1930), a significant expansion of the FDA’s reach sprang from the elixir sulfanilamide disaster which resulted in the deaths of more than 100 people in 1937. Under the Roosevelt administration this was an opportunity to be seized, and the Federal Food, Drug and Cosmetic Act (FFDCA) was passed in 1938 under which Congress “gave authority” to the Food and Drug Administration to oversee the safety of food, drugs, and cosmetics.
The July 19 announcement allayed concerns that the FDA was going to regulate every app somehow related to food, or drugs, or cosmetics. The press release said the agency would attempt to regulate only “a small subset of mobile medical apps that impact or may impact the performance or functionality of currently regulated medical devices.” These would include, initially at least: