FDA draft document offers guidelines – and raises questions
The questions and comments are pouring in over the U.S. Food and Drug Administration’s draft guidance on mobile medical apps, making it obvious that the government’s first attempt to clarify its regulatory authority over this fast-growing field won’t be the last.
While the 30-page draft establishes three categories of devices that would fall under FDA perusal, it leaves out – either specifically or by omission – several other uses. Among them: App sellers (like Apple), telecommunications providers and handset manufacturers, to name a few.
“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,” said Bakul Patel, an FDA policy advisor who helped draft the guidelines, in news reports. “We wanted to make sure that we are consistent in regulating medical devices so nothing has changed. … (If) somebody makes a stethoscope on an iPhone, it doesn’t change the level of oversight we have of a stethoscope.”
Chuck Parker, executive director of the Continua Health Alliance, a 230-member global alliance of healthcare and technology companies working to improve the quality of personal healthcare, said the draft “opens up the market” by giving the industry rules to work with.
“It sort of clears the thoughts out a little bit, and that does help us out,” he said.
“It’s pretty consistent with what I expected them to do,” said Yarmela Pavlovic, an associate with the global law firm of Hogan Lovells. “What’s been happening (in the mobile medical app space) is very, very fast development, and there needed to be an interpretation of existing regulations”
Zachary Bujnoch, a senior industry analyst for telehealth and healthcare with Frost & Sullivan, called the draft document a much-needed entry into a “market full of hype.” He said the regulations will help “vet out the market” and target the thousands of healthcare apps on the market.
“This is going to hinder innovation in the market – there’s no doubt about it,” he said. “But that’s good. It’s a very confused market right now … that needs clarification.”
Pavlovic said she was “surprised by the way they narrowed” the classifications of apps to come under FDA guidance. “There’s definitely things that fall outside the categories that will be discussed,” she said. For example, she said, should product accessories be treated the same as devices?