Tuesday, September 30, 2014

Is The FDA Even Capable of Regulating 21st Century Medical Devices?

he pace of innovation in medical devices is breathtaking. The most exciting developments are in mobile health. One year ago this month, the Food and Drug Administration (FDA) issued its final regulations on mobile medical apps. So far this year, the FDA has approved 23 medical apps that the editors of MobileHealthNews define as “notable.”

The role of the FDA in preventing such apps from reaching patients is of great concern. Mobile technology is so well integrated with other technologies that we now take for granted that FDA regulation of these apps risks giving the FDA power over tools that we’ve used conveniently for years. Many were relieved when the South Korean FDA announced in March that it would not regulate Samsung’s latest Galaxy smartphone!

Well, the whole issue may become irrelevant. Ordinary citizens are hacking medical devices to improve them, ignoring the FDA completely.

Read the entire column at NCPA's Health Policy Blog.

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