WASHINGTON - Tools that let smartphones monitor blood sugar or work as stethoscopes may face the same regulatory scrutiny as heart stents and ultrasound machines.
Such applications pose a potential risk and may have to meet Food and Drug Administration standards for medical devices, according to draft guidelines issued yesterday.
The FDA is focusing on apps that directly diagnose or treat conditions such as diabetes or that transform the smartphone into a medical device. The regulations would be the first for a market that Ilkka Korhonen, a former senior manager of Nokia Corp.’s wellness business program, estimates may climb to $6 billion in 2015.
