Anytime FDA starts proposing new regulations for medical devices, designers understandably get wary. But according to experts, the administration’s proposed regulations for medical mobile apps might result in more clarity than confusion.
According to the draft guidance issued last week, FDA is proposing to regulate apps that “are used as an accessory to a medical device already regulated by the FDA” or “transform a mobile communications device into a regulated medical device by using attachments, sensors or other devices.”
That stance, says Nancy Taylor, a partner in law firm Greenberg Traurig’s Washington, DC-based health and FDA practice, is not a radical departure from how FDA has handled other device software issues.
“This rule … is not inconsistent with how they’ve been treating medical software,” Taylor says. “What they’ve done is given better guidance this time around than they’ve ever done before.”
Moreover, Taylor says many developers selling apps that meet FDA’s proposed definition of mobile medical applications have already had their products cleared with the agency. For those who are unsure if apps they have already developed or are dreaming up fit the bill, she suggests taking a close look at Appendix A of the draft guidance document, which lays out examples of what the administration defines as mobile medical apps.
“It takes all jargon from the guidance document itself … and shows what they’re thinking and how it applies to actual devices in operation,” Taylor says.
Zack Bujnoch, a senior industry analyst for telehealth at business research and consulting firm Frost & Sullivan, says if the guidelines are adopted, it’s going to cost apps developers. Developers will have to spent time and money on efforts such as defining what class of device their application falls under, complying with labeling requirements, getting FDA clearance, and ensuring they have quality assurance systems in place.
“The bottom line is you’re going to spend a lot more money in development of that application,” Bujnoch says.
However, regulation will also serve to weed out apps that make bogus healthcare claims. If healthcare professionals know which products they can trust, they’re more likely to use them and recommend them to patients, Bujnoch says.
“It will be a benefit for this market in the long run, even though it might stifle innovation here and there,” he says.
The period for public comment on the matter ends Oct. 19, and Miki Kolton, of counsel in Greenberg Taurig’s health and FDA practice, says designers should take the opportunity to have their voices heard.
“If they want to influence a business model for themselves, they should look at this and get on the record,” she says.
—Jamie Hartford
