The growth of health-related mobile applications for smartphones and
wireless tablets like the iPad has blurred the lines between these
consumer devices and regulated medical devices, spurring the US Food and
Drug Administration (FDA) this week to release its first guidelines for
regulating mobile apps. FDA has identified the types of apps it deems
fall under its purview—those doctors would likely use to diagnose or
monitor a patient's medical condition. These include apps that affect
how a currently regulated medical device performs or functions, and
those that can turn a smartphone or tablet into a regulated device, such
as a blood glucose meter. “We wanted to make sure that we are
consistent in regulating medical devices so nothing has changed,” said
Bakul Patel, an FDA policy adviser who helped create the guidelines. If
“somebody makes a stethoscope on an iPhone, it doesn’t change the level
of oversight we have of a stethoscope.”
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