The hundreds of mobile health applications produced each month outpaces the Food and Drug Administration’s ability to regulate them, a policy adviser to the agency said last month.
“The whole mobile app world has its own ecosystem where things live, die and sort of recycle again…and it’s mostly consumer driven,” said Bakul Patel, senior policy adviser for FDA’s Center for Devices and Radiological Health at a roundtable discussion on medical device security in June.
“The end-of-life cycles [are] so short compared to any other products we’ve ever seen,” he said.
The rate of innovation in the mobile marketplace has led the agency to target apps that “present a greater risk to health.”
The FDA has long held that the agency doesn’t plan to scrutinize all health apps, especially low-risk “health and fitness tools,” just ones used as accessories for a regulated medical device or those that “transform a mobile platform into a regulated medical device.”
The FDA has reviewed about 100 health apps, while hundreds of apps continue to appear on the Apple iTunes Store and Google Play store each month, potentially avoiding federal regulation. The FDA also just published guidelines freeing developers of healthcare information technology to build systems free of regulatory oversight, even in the case of devices that “straddle the line” between medical device and information technology, reports the Federal Times.
Lawmakers have repeatedly called on Congress to create a special office within the FDA to regulate mobile apps. An FDA spokeswoman told the NewsHour that the agency, as a matter of policy, does not provide comment on proposed or pending legislation.
Editor’s note: We corrected Patel’s title in the second paragraph and removed a quote incorrectly attributed to Patel, commenting on the FDA’s inability to open a special office to regulate apps. We added that the FDA is unable to have an official position on the proposed legislation.