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FDA unveils guidelines for medical devices

Posted: 05 Dec 2013     Print Version  Bookmark and Share

Keywords:FDA  medical device  medical app  interoperability 

This year, the Food and Drug Administration (FDA) has issued guidance on how it views mobile medical apps as well as security and wireless technology choices in medical devices. The agency also hopes to release guidelines on interoperability next year.

"We are very committed to the appropriate balance between benefits and risks and bringing new technology to patients as quickly as possible," William Maisel, chief scientist of the FDA's Center for Devices and Radiological Health stated.

The FDA is to some extent playing catch up with a fast moving industry. The agency has long been criticized for being slow and opaque in its decisions. Device makers often launch their latest products in Europe and Asia where regulatory processes move more quickly.

The agency aims to deliver smart regulations appropriate to emerging technologies, Maisel said. "We shouldn't regulate just because we can or always have regulated that way," he said noting the FDA is scaling back from the old Class I, II and III buckets originally created by congress.

For example, the FDA aims to regulate only a small subset of medical apps, focusing on those where patient risk is greatest. To date the FDA has evaluated about 100 medical apps, the first one about a decade ago. The Apple Store alone hosts 43,000 health apps, 19,484 of which could be considered medical apps, he said.

"A large number of medical apps will not be regulated because the patient risk is sufficiently low—the part we focus on is really just the tip of the iceberg," Maisel said.

Earlier this year, the FDA published its final guidelines on choosing wireless networks for medical devices, focusing on issues such as co-existence, quality of service and security. "We do not regulate smartphones and tablets, but if you transform a smartphone into a device to monitor cardiac status, for example, we will" regulate it, he said.

The agency this year also published its recommendations for security issues medical device designers need to consider. "We are aware of devices affected by malware, including implanted devices, and we know of uncontrolled distribution of passwords including to tech support personnel, he said.

In August, the FDA published a list of 14 interoperability standards it will recognize, and it hopes to release guidelines on interoperability in 2014. "It will not be proscriptive about what you must do but will provide considerations to take into account," he said.

As many as 500 million smartphone users will employ health apps by 2015, according to one 2010 study he cited. Another report estimates the mobile health market will grow to revenues of $26 billion by the end of 2017.

Overall," health care delivery is vastly different even from a decade ago," Maisel said. "Much more often patients are going home more quickly, and consumers are making their own diagnosis on their smartphones over the Internet," he added.

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