Mobile medical apps need to be regulated because patient safety is at risk when they are used to diagnose or treat a disease, said Jeffrey Shuren, director of the Food and Drug Administration's Center for Devices and Radiological Health at a Nov. 19 House Energy and Commerce Committee subcommittee on health hearing.
The FDA's regulation of software as a medical device is based on risk and function, Shuren told the panel, and the FDA treats devices that perform the same function the same way regardless of the platform on which it is used.
"It's not about the platform. It's about the function," said Shuren.
Software becomes a medical device through intended use and diagnosis of disease and conditions or treatment cure mitigation of disease, he said.
"All we are saying is, the functions, when they stay the same, treat them the same, because the impact and the risk to patients is the same," Shuren said. "Simply because they got smaller and I can pick it up and walk out of the room with it, doesn't change the risk to the patients. Why for that reason alone would we treat it differently?"
The FDA issued nonbinding guidance Sept. 25 with their plan of how to regulate mobile apps as medical devices.
If, for instance, an app illuminates an LED light, like prevalent flashlight apps do, the FDA wouldn't consider it a medical device. But if the developer labels and markets it as a light source for doctors to examine patients, the FDA would approach it as it would an ophthalmoscope, the guidance says.
But the FDA might not need that guidance if Congress passes a bill that's currently sitting in the House Energy and Commerce Committee.
The bill (H.R.3303) would amend the Food, Drug and Cosmetic Act to regulate medical software. It would establish three categories of software--clinical, health and medical--with the two former software types not subject to FDA regulation.
But Shuren told the subcommittee that the bill undermines the FDA's authority to assure the safety and effectiveness of high risk medical devices.
The FDA would no longer be able to regulate blood glucose meters and software that is used to analyze pap smear slides, Shuren said.
"It's very confusing to us what this actually accomplishes," he said.
Via Parag Vora