Bakul Patel, a FDA policy adviser who helped craft the guidelines, said the agency sought to balance the potential for innovation with patient safety in the rapidly changing mobile space.
“What we have done is we have taken that approach and formulated policies that were narrowly focused on a very small subset while allowing apps that are out there to foster and continue developing that space,” he said.
The guidelines suggest three types of applications should require the FDA’s sign off: a mobile application that acts as an accessory to a regulated medical device, turns a mobile gadget into such a device or makes suggestions regarding a patient’s diagnosis or treatment.
For example, an app that allows radiologists to view X-rays on an iPad or that turns an Android phone into a heart monitor would be regulated. But an app that stores medical records or provides training videos to physicians would not.
“We wanted to make sure that we are consistent in regulating medical devices so nothing has changed,” Patel said. If “somebody makes a stethoscope on an iPhone, it doesn’t change the level of oversight we have of a stethoscope.”
The draft rules should be familiar terrain for regulators, who have already grappled with the risks and red flags associated with similar devices.
“If I’m using a traditional medical device and I’m expecting it to be safe and effective, just because it’s on a mobile platform those same expectations apply. And the same risks… also apply,” said Jeff Shuren, director for the FDA’s Center for Devices and Radiological Health.
The guidelines won’t be enforced until the agency collects feedback over the next 90 days from manufacturers and health care providers. The proposals come as some industry groups have pressed the agency to outline its intentions in hopes of eliminating the kind of regulatory uncertainty that can make investors and companies skittish about backing a product.
“We have been asked by many different groups in the past [for guidance],” Patel said. “We are listening to them and responding to them.”
At the same time others have suggested that the federal agency may not be able to effectively monitor mobile and information technology products because they evolve more quickly than other medical devices.
Shuren said the faster pace of change has prompted the agency to take a more flexible approach in its reviews. For example, some software manufacturers could prove their product is accurate based on its design rather than trials in a clinical setting.
“We are seeing these kind of software programs develop and we’re seeing that happen in the future,” Shuren said. “We are trying to get out ahead of technology so we’re prepared and allow these technologies to be developed quickly and modified quickly.”