A similar version of this Health Alert appeared at Forbes.
1976: The United States celebrated the bicentennial of our independence; Jimmy Carter was elected president; young men wore bell bottoms and middle-aged ones wore leisure suits; advertising encouraged women to smoke Kool cigarettes. And the Food and Drug Administration (FDA) first regulated medical devices.
Although we fantasized about having Captain Kirk’s communicator or Dr. McCoy’s tricorder, nobody would have known what to do with an actual smartphone or tablet, had they existed in those days. Today, increasing numbers of us use them to keep track of medical information, to remind us to take our meds or do countless other tasks important to our health. In 2013, the Apple app store had 97,000 mobile health apps, and over 60 percent of physicians were using tablets.
And yet, the FDA is still regulating these 21st century technologies under legislation passed when Wings’ Silly Love Songs topped the pop music charts. It’s past time for Congress to amend the Food, Drug and Cosmetic Act to clarify the FDA’s regulatory authority over these new tools for our health.
According to the 1976 amendments, a medical device is an “instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory…” [21 U.S.C. 321(h)]. That does not really give the FDA much direction with respect to apps, smartphones and tablets, does it?
Left to its own devices (excuse the pun), the FDA has actually done a very effective job of letting the industry and patients know how it intends to regulate these new technologies. Dr. Jeffrey Shuren, Director of the Center for Devices and Radiological Health, and Bakul Patel, who is responsible for writing the FDA’s final guidance, promised a light regulatory touch. The final guidance was published in September 2013, at which time the FDA noted, “The agency has cleared about 100 mobile medical applications over the past decade; about 40 of those were cleared in the past two years.”