FDA Regulation of Wireless Devices

What if everyone wore mobile wireless devices, but some nefarious parties could somehow send signals and interfere with them? This dark scenario was brought to my attention in an article distributing during yesterday’s seminar on cyber-security. As Ray Kurzweil wrote, science fiction writers used to write about robots as “us versus them,” but the problem gets stranger when “us” is them. Science fiction is becoming science fact with the advent of mobile body area networks.

A mobile body area network (MBAN) is a wireless system that uses low-cost wearable sensors that allow doctors to remotely monitor patent vital signs. The FCC has an agreement with the Food and Drug Administration to help streamline approval processes for medical devices that use wireless spectrum. The two agencies are supposed to collaborate on approving each device, with the FCC handling the technical side and the FDA scrutinizing the medical aspects of the device.

The FDA has clashed with makers of mobile apps that the agency says are meant to diagnose or offer treatments for diseases — an area that falls under the agency’s authority, it says. Some software developers have chafed under the traditional requirements for approving medical devices, such as clinical trials.

Right now the clash is over the FDA’s position that mobile apps will be regulated as medical devices if they purport to do things that medical devices can do. This means manufacturers will have to meet the usual FDA medical device legal and regulatory requirements, including filing a 510(k), if appropriate, etc. In the last few days I have met more people in the business community involved in augmented reality. Our law firm represents medical device manufacturers, mobile app manufacturers, distributors of FDA-regulated products (including dietary supplements), and health-related start-ups, so these developments are of keen interest. In an age of virtual reality and cyborg post-humans, we are rapidly becoming living mobile medical devices. The question is how far and how deep FDA regulation will penetrate into our physical lives. Contact our FDA attorneys if you have legal questions about FDA regulation of wireless devices, mobile applications, or FDA laws in general.