FDA Moving Toward Regulation of Medical Apps, Experts Warn
The Food and Drug Administration is quietly moving toward the regulation of medical apps, much like it regulates software embedded in medical devices, speakers warned at an American Enterprise Institute panel in Washington Wednesday. Last July, the FDA issued draft guidance on mobile medical applications and has collected comments on what to do next. Speakers warned that regulation appears likely. The development comes as the FCC puts increasing emphasis on medical uses for broadband, one of the chapters of the National Broadband Plan.
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The FDA is looking to “expand its mission” to regulate “one of the more dynamic and important interesting technologies going on in healthcare,” said J.D. Kleinke, an AEI scholar. “This is the demilitarized zone in terms of health policy. … For the most part, health information technology is an absolutely politically neutral zone.” But now the FDA is about to step in to regulate an area where the government has not been involved in the past, he said. “Suddenly we have a spoiler.”
More consumers and doctors are using mobile apps, and under draft FDA rules, some categories of medical apps would need to be approved under the agency’s regulatory structure, said Joel White, executive director of the Health IT Now Coalition. “How FDA categorized the apps is really important,” White said. Under the draft, FDA would regulate apps that “display, store or transmit data in its original format,” control a medical device “whether remotely or through direct connection,” turn a “mobile platform into a medical device” or “create alarms or data based on a medical device,” White said.
The big problem is that under the draft, medical apps would need to be cleared under the FDA’s 510(k) process, as established by that section of the Food, Drug and Cosmetic Act, White said. “The 510(k) process in itself is not generally known as a rapid process,” he said. “If you think about the life cycle of apps and software generally, that life cycle is very rapid.” Just changing an app to make it work better, might trigger the need for additional clearance from the FDA, he said. Testing is also expensive, accounting for up to 77 percent of the cost of bringing devices to market, White said. “People are using the technology so how it’s regulated matters very much,” he said.
Kleinke noted that medical devices are generally something “that could physically kill you if something goes wrong.” That’s why “the 510 (k) process is a very serious one,” he said. “It’s very different than ’this works on my phone or not.'"
"Every person in our organization is interested in pushing the envelope as far and as fast as they can,” said Jon Potter, president of the Application Developers Alliance. “You need an investor. … Investors are always looking at regulatory challenges as impeding their interest in investing.”